Configurable Intervertebral Implant

ABSTRACT

The present disclosure relates to a surgical device, such as a surgical implant, which may be used in several types of procedures. More specifically, the present disclosure relates to implants for use in an anterior, posterior, posterior lateral or direct lateral approach to the disc space. The surgical device may be manipulated in various manners to accommodate delivery through a minimally invasive portal in one configuration and adjusted to a second configuration once placed in the intervertebral space. A delivery system for placing the surgical device in a body is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/859,828, filed Sep. 21, 2015, now U.S. Pat. No. 10,159,475, issuedDec. 25, 2018, which is a continuation-in-part of U.S. patentapplication Ser. No. 14/286,639, filed May 23, 2014, now U.S. Pat. No.9,615,938, issued Apr. 11, 2017, and claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 62/052,790, filed Sep. 19,2014. U.S. patent application Ser. No. 14/286,639 is acontinuation-in-part of U.S. patent application Ser. No. 12/434,328,filed May 1, 2009, now U.S. Pat. No. 8,734,515, issued May 27, 2014which in turn claims priority to U.S. Provisional Application No.61/051,036, filed on May 7, 2008. Each of these applications isincorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present disclosure relates to the field of medical devices and isgenerally directed towards a device for insertion between two adjacentvertebral bodies and to devices for distracting two or more anatomicalfeatures. The device may be manipulated in various manners toaccommodate delivery through a minimally invasive portal in oneconfiguration and adjusted to a second configuration once placed in theintervertebral space. The device may also be adapted for use with aspecific patient in a surgical setting and have contact surfaces withshapes based on the patient's unique anatomical features.

BACKGROUND OF THE INVENTION

Individuals who suffer degenerative disc disease, natural spinedeformations, a herniated disc, spine injuries or other spine disordersoften require surgery on the affected region to relieve the individualfrom pain and prevent further injury. Such spinal surgeries may involveremoval of damaged joint tissue, insertion of a tissue implant and/orfixation of two or more adjacent vertebral bodies, with the surgicalprocedure varying depending on the nature and extent of the injury. Forpatients with varying degrees of degenerative disc disease and/or nervecompression with associated lower back pain, spinal fusion surgery orlumbar arthrodesis (“fusion”) is commonly used to treat the degenerativedisease. Fusion commonly involves distracting and/or decompressing oneor more intervertebral spaces, followed by removing any associated facetjoints or discs, and then joining or “fusing” two or more adjacentvertebra together. Fusion of vertebral bodies also commonly involvesfixation of two or more adjacent vertebrae, which may be accomplishedthrough introduction of rods or plates, and screws or other devices intoa vertebral joint to join various portions of a vertebra to acorresponding portion on an adjacent vertebra.

Fusion may occur in the lumbar, thoracic or cervical spine region of apatient. Fusion requires tools for accessing the vertebrae andimplanting the desired implant, any bone graft or bioactive material,etc. Such procedures often require introduction of additional toolsand/or instruments, including drills, drill guides, debridement tools,irrigation devices, vises, clamps, cannulae, retractors, distracters,cutting tools, cutting guides and other insertion/retraction tools andinstruments to prepare the space for achieving fusion. The insertion,alignment and placement of these surgical devices are critical to thesuccess of the operation. As such, providing an adjustable or otherwiseconfigurable surgical device or implant, which is flexible andconfigurable to meet the particular patient's needs and any existingconstraints, increases the likelihood that the surgical procedure willbe successful.

Given the complexities of surgical procedures, as well as anatomicalvariation between patients who receive surgical devices, it is oftenchallenging to provide a device or implant that achieves the needs of aparticular patient without completely customizing the device or implantfor a single patient. In particular, implants are often designed forease of use during insertion, but compromise the implant's ability toprovide adequate support or fail to properly restore disc height, forexample. Thus, there is a present and long felt need to provide animplant which may be manipulated in various manners according to thestage of the surgical procedure, and in particular accommodate deliverythrough a minimally invasive portal. There is also a present need for animplant that may quickly, easily and efficiently be manipulated in aplurality of configurations.

Although expandable implants have been proposed, the prior art fails toteach the novel aspects of the present disclosure. For example, priorart implants are not suitable for use in a surgical procedure where theimplant is first inserted through a minimally invasive portal, theneasily manipulated and configured to conform to the patient's anatomicalfeatures and provide better stability and/or load sharing. Currentimplant designs also do not assist the surgeon in completing thesurgical procedure(s) quickly, safely and efficiently, and are alsosubject to the problems and risks noted above. Other advantages over theprior art will become known upon review of the Summary and DetailedDescription of the Invention and appended drawing figures.

SUMMARY OF THE INVENTION

The present disclosure relates to surgical devices, including surgicalimplants, which may be used in several types of procedures. Morespecifically, but not exclusively, the present disclosure relates toimplants for use in an anterior, posterior, posterior lateral or directlateral approach to the disc space.

Intervertebral discs, which are located between endplates of adjacentvertebrae, normally stabilize the spine and distribute forces betweenthe vertebrae and cushion vertebral bodies. The spinal discs may bedisplaced or damaged due to trauma, disease or aging. Displacement ordamage to the intervertebral discs may result in nerve damage, pain,numbness, muscle weakness, and even paralysis. Furthermore, as a resultof the normal aging processes, these discs dehydrate and harden, therebyreducing the disc space height and producing instability of the spineand decreased mobility.

Access to a damaged disc space may be accomplished from severalapproaches to the spine. One approach is to gain access to the anteriorportion of the spine through a patient's abdomen. A posterior approachmay also be utilized. A posterior lateral approach, such as thetransforaminal approach, may also be utilized. A direct lateral approachmay also be employed.

While it is desirable in these approaches to place one or more implantsinto a single disc space so that the load of the spinal column is evenlydistributed, implants are often designed to facilitate placement througha single approach; however, implants designed for a single approachsacrifice key implant features necessary to accomplish the goals of thesurgical procedure. In addition, accurate placement, and subsequentmanipulation of implants in the disc space has heretofore been extremelydifficult, particularly in light of the complexity associated with priorart expandable implants.

According to one aspect of the present disclosure, a surgical device isdescribed which may be manipulated in various manners to accommodatedelivery through a minimally invasive portal in one configuration andadjusted to a second configuration once placed in the intervertebralspace. Varying embodiments described herein permit a surgeon or othermedical professional to quickly and easily manipulate the implant toachieve one or more configurations as required for the particularapproach and/or operation. The adjustable surgical devices describedherein provide an advantage over the prior art, in particular byproviding one or more adjustable features for maximizing theeffectiveness of the surgical device, which in turn reduces thelikelihood of misalignment, misplacement and subsequent mistake duringthe surgical procedure(s).

According to another aspect of the present disclosure, a surgical deviceis described which includes one or more adjustable features forachieving a desired outcome for a particular surgical procedure. Morespecifically, surgeons have the ability to readily convert magneticresonance imaging (MM) data or computed tomography (CT) data into a dataset readable by computer-aided design (CAD) program and/or finiteelement modeling (FEM) program. This data may be used to create asurgical plan that accounts for unique anatomical variations and otherconstraints, and permits the surgeon to efficiently insert, place andmanipulate the device or implant within an intervertebral space. Thus,the surgical device of one embodiment may be inserted in a firstconfiguration and then adjusted to a second configuration that allowsthe structural aspects of the surgical device to be accurately alignedwith the structural needs of the patient.

Incorporated by reference in their entireties are the following U.S.patents and patent applications directed generally to methods andapparatus related to surgical procedures, thus providing writtendescription support for various aspects of the present disclosure. TheU.S. patents and pending applications incorporated by reference are asfollows: U.S. Pat. Nos. 7,957,824, 7,844,356, 7,658,610, 6,830,570,6,368,325, 3,486,505 and U.S. Pat. Pub. Nos. 2010/0217336, 2009/0138020,2009/0087276, 2008/0161817, 2008/0114370, and 2007/0270875.

Additionally, U.S. Pat. Nos. 8,758,357 and 8,870,889 and U.S. PatentPublication No. 2014/0350614 are incorporated by reference for theexpress purpose of illustrating a system and method for creating animplant, such as the one described herein, using additive manufacturingor other techniques, wherein the implant incorporates one or morepatient-matched surfaces or is otherwise customized to a particularpatient.

One aspect of the present invention is to provide a surgical device forinsertion in an intervertebral space between adjacent vertebrae. Thedevice includes, but is not limited to: (1) a first module including abore; (2) an armature that is slidingly engagable in the bore of thefirst module; and (3) a second module connectable to a distal end of thearmature such that the surgical device has an adjustable configurationachieved by adjustment of the position of the armature within the boreof the first module. A plurality of second modules of a variety ofshapes and sizes may be provided for connection to the armature.

The device can be assembled during a surgical procedure. Thus, thearmature can be introduced at least partially into the bore during thesurgical procedure. A second module of a desired size and shape may beselected by a surgeon during a surgical procedure. The selected secondmodule can then be connected to the armature during the procedure. Thedevice may then be inserted into the intervertebral space. Further, thedevice may be removed from the intervertebral space, at least partiallydisassembled, and a different second module selected and interconnectedto the armature.

In one embodiment, the armature is slidingly adjustable with respect tothe first module. In another embodiment, the armature is rotatablyadjustable in the bore of the first module. Thus, the armature may berotated axially while the first module remains substantially stationary.Patient specific surfaces may be formed on exterior surfaces of thesurgical device, the surfaces adapted to substantially conform to aselected portion of the patient's anatomy. In one embodiment, the secondmodule includes a patient specific surface. In another embodiment, thefirst module includes a patient specific surface.

In one embodiment, the armature is adapted to be adjusted afterinsertion of the surgical device in the intervertebral space to extendthe surgical device across a portion of the disc space to providebi-lateral support to the adjacent vertebrae. Optionally, the surgicaldevice may include a stop to maintain the armature and the second modulein a desired position. The stop may comprise an aperture formed in thefirst module that is adapted to receive a threaded fixture that can berotated to apply a force to the armature. In another embodiment, thesurgical device includes three adjustable armatures. Each armature mayinclude a module. In another embodiment, the surgical device includesthree modules at a distal end, the first module in a medial position,and two modules at a proximal end.

The surgical device may further comprise an aperture communicating witha bore in the surgical device. The aperture is operable to receiveimplant material and the bore is operable to deliver the implantmaterial through the surgical device to at least partially fill theintervertebral space around the surgical device with the implantmaterial.

In one embodiment, the second module is operable to at least partiallydistract the adjacent vertebrae. The second module may have a taperedshape with a decreased thickness at a portion of the second moduledistal to the first module.

In another embodiment, the surgical device has an insertionconfiguration with a first width sized to be received between theadjacent vertebrae. The surgical device has a deployed configurationwith a second width that is greater than the first width.

It is another aspect of the present invention to provide a spinalimplant adapted for insertion in a space between adjacent vertebrae. Thespinal implant includes: (1) a primary module; and (2) a firstadjustable armature and a second adjustable armature interconnected tothe primary module, the first and second adjustable armatures eachincluding a proximal end with a proximal module and a distal end with adistal module.

The proximal modules and distal modules may be interconnected to theadjustable armatures during a surgical procedure. Each of the proximaland distal modules may be exchanged for modules of different sizes andshapes. The first and second adjustable armatures are operable to movein relation to the primary module to change a position of the proximaland distal modules. In one embodiment, the first and second armaturesare formed of a flexible material. In another embodiment, the first andsecond armatures are formed of a material with shape memory. Optionally,at least one of the first and second armatures is substantially linear.In another embodiment, at least one of the first and second armatureshas a generally arcuate shape. The spinal implant may be formed suchthat at least a portion of each of the distal modules is thinner thanthe primary module. In another embodiment, the spinal implant includes avoid in the primary module. The void is adapted to receive implantmaterial.

In yet another aspect of the present invention, an assembly foraccessing an intervertebral space and inserting a spinal implant betweenadjacent vertebrae is provided. The assembly generally comprises: anaccess port and an implant. The access port may include a cannula with abody. The cannula body includes a bore and a distal end with distractorplates, the distractor plates forming a tip adapted to at leastpartially distract the adjacent vertebrae a first distance.

The access port also includes a distractor with at least one distractorblock sized to move through the cannula bore. the distractor block areadapted to move the distractor plates to an expanded position such thatthe distraction of the adjacent vertebrae is increased to a seconddistance that is greater than the width of the cannula. The access portfurther includes a shaft with a second bore, the second bore adapted toguide an implant to the intervertebral space, the expansion tube sizedto fit within the cannula bore and move the distractor block radiallybeyond a width of the cannula body to increase the distraction of theadjacent vertebrae to a third distance. In one embodiment, thedistractor includes one distractor block. In another embodiment, thedistractor includes two distractor blocks. In still another embodiment,after the distractor block is in the radially extended position, asecond distractor with at least one second distractor block is insertedin the cannula bore. Thereafter, the expansion tube can be used to movethe second distractor block radially beyond the cannula body to increasethe distraction to a fourth distance greater than the third distance.

The implant is sized to fit through the second bore of the expansiontube and generally includes a first module and at least one armatureadjustable with respect to the first module. A distal module isinterconnected to a distal end of the armature. The implant may alsoinclude an engaging portion for engagement by a tool used to move theimplant through the second bore of the expansion tube into theintervertebral space. In one embodiment, the engaging portion includesan aperture formed in the first module, the aperture including internalthreads. The engaging portion may be adapted to be manipulated by thetool to lock the armature in a desired position. Optionally, theengaging portion protrudes from a surface of the at least one of themodules.

In one embodiment, the position of the armature is adjustable by thetool used to move the implant. Optionally, the armature may include afirst portion rotatably interconnected to a second portion. Thus, thedistal module is radially adjustable with respect to the first module.

In another embodiment, an exterior surface of at least one of themodules includes a plurality of one of the set comprising grooves,protrusions, and spikes.

The cannula body may include at least one longitudinal corner with arounded edge to facilitate axial rotation of the cannula body betweenthe adjacent vertebrae. In one embodiment, an exterior surface of theexpansion tube shaft is keyed to engage a predetermined portion of thecannula bore.

In accordance with an aspect of the present invention, a method ofinserting implant material into an intervertebral space is disclosed.The method includes, but is not limited to, the steps of: (1)positioning a leading end of a surgical device between adjacentvertebrae in first orientation, the leading end having a first dimensionaligned with a rostral-caudal direction and a second dimension largerthan the first dimension and aligned in a lateral direction; (2)rotating the leading end of the surgical device relative to the adjacentvertebrae to align the larger second dimension with the rostral-caudaldirection and distract the adjacent vertebrae; (3) loading the implantmaterial into a cannula, wherein the implant material is not undercompression during the step of rotating; and (4) subsequent to the stepof rotating, advancing the implant through the cannula and into theintervertebral space from the leading end.

In some forms, the step of positioning includes compressing the leadingend in the rostral-caudal direction.

In some forms, the step of loading is prior to the step of positioning.

In some forms, the step of advancing the implant material includesexpanding the leading end via force exerted by the implant material, theforce received from an advancing rod.

In some forms, the method includes the step of selecting the implantmaterial from one or more of fusion devices and bone graft material.

In some forms, the step of positioning includes determining a positionof the surgical device by placing stops formed on the leading endagainst the adjacent vertebrae.

In some forms, the method further includes the step of preparing,wherein the step of preparing includes one or more of removing naturalspinal disc material and determining geometrical features of theintervertebral space.

According to various embodiments, the implant may also comprise one ormore patient-contacting surfaces formed to be substantially congruentwith the anatomical features of a patient. The preconfigured implant maybe configured such that the patient-contacting surfaces are configuredto contact the plurality of anatomical features in a mating engagement,to ensure proper orientation, insertion, alignment and placement of theimplant.

According to one aspect of the present disclosure, a surgical device isdisclosed, which may further comprise one or more features for receivingat least one instrument. In one embodiment, the instrument may be usedfor distraction and insertion of one or more surgical devices, such asby way of example between adjacent vertebrae. The instrument maycomprise an elongated barrel, an operative end formed on adistally-located end of the barrel, the operative end provided forengaging the adjacent vertebrae. The operative end of the barrel mayinclude a plurality of slots allowing at least the operative end to beexpanded.

According to one embodiment, the instrument further comprises a majordimension and a minor dimension, a cannula leading from aproximally-located portion of the barrel to an opening thereof, theopening at the operative end for disposing of the implant materialtherefrom. According to this embodiment, the operative end minordimension is sized to be received between the adjacent vertebrae in aninitial insertion, the major dimension is sized for distracting theadjacent vertebrae to permit the surgical device to be disposedthereinto, the vertebrae being distracted by rotation of the operativeend after the initial insertion, and the surgical device is retainedwithin the cannula without significant compression during rotation ofthe operative end.

In some forms, the surgical device further includes a loading chamberfor loading of the implant material into the cannula and a reciprocablerod disposed at least partially in the cannula for advancing the implantmaterial therethrough and from the opening. The cannula may have anon-uniform size such that the cannula is smaller at the opening. Theimplant material may be advanced through the opening to expand theoperative end. The implant material may be advanced through the openingto at least partially distract the adjacent vertebrae.

In some forms, the rod may be advanced by actuation of a trigger,rotating knob, or other actuator, operatively connected to the rod.

In another aspect, a surgical device for distraction and insertion ofintervertebral implant material in an intervertebral space betweenadjacent vertebrae is disclosed. The surgical device may include, but isnot limited to: (1) an elongated barrel; (2) an operative end formed ona distally-located end of the barrel, the operative end for engaging theadjacent vertebrae and the operative end including a plurality of slotsallowing at least the operative end to be expanded; (3) a cannulaleading from a proximally-located portion of the barrel to an openingthereof, the opening at the operative end for disposing of the implantmaterial therefrom; and (4) an inner member reciprocable within thebarrel and having features located thereon for engaging surfaces of theslots of the barrel, movement of the features against the surfacesexpanding the barrel and distracting adjacent vertebrae when theoperative end is located thereat. The operative end of the barrelincludes a rostral-caudal dimension and a lateral dimension. Theoperative end rostral-caudal dimension is sized to be received betweenthe adjacent vertebrae in an initial insertion,

In some forms, the slots are angled, and the inner member features arewedge-shaped for contacting the angled slots. Retraction of the innermember in a direction away from the operative end may force the wedgesthrough the slots to expand the barrel in the rostral-caudal dimension.

In some forms, surgical device may include stops for maintaining thefeatures in the desired position along the slots.

In some forms, the surgical device further includes a loading chamberfor loading of the implant material into the cannula. A reciprocable rodmay be included and disposed at least partially in the cannula foradvancing the implant material therethrough and from the opening.

In some forms, the implant material may be advanced through the openingto at least partially distract the adjacent vertebrae.

In some forms, the rod may be advanced by actuation of a trigger,rotating knob, or other actuator, operatively connected to the rod.

In some embodiments, the surgical device comprises a component formating and/or docking against one or more anatomical features of apatient.

In some embodiments, the surgical device comprises a cam mechanism thatpermits a user to at least partially distract adjacent vertebrae.

In some embodiments, the surgical device comprises a barrel that permitsa user to at least partially distract patient tissue and/or dilate thebarrel for use of the surgical device in a minimally invasive surgicalprocedure.

Another aspect of the present invention is a system for distraction andinsertion of implant material in an intervertebral space betweenadjacent vertebrae. The system may include, but is not limited to asurgical device and a cannula.

The surgical device includes a barrel with a longitudinal length from adistal end to a proximal end. An operative end of the barrel is fixedlyattached and integral to the distal end of the barrel. The operative endcomprises: a longitudinal length from a distal end to a proximal end; afirst and second major straight side comprising a first dimension; afirst and second minor straight side comprising a second dimension thatis smaller than the first dimension; a first slot that separates thefirst major straight side into two parts; a second slot that separatesthe second straight major side into two parts; a third slot thatseparates the first minor straight side into two parts; and a fourthslot that separates the second minor straight side into two parts.

The cannula comprises a cannula body that extends along the longitudinallength of the barrel or the surgical device. The cannula body extendsthe entirety of the longitudinal length of the surgical device andterminates at or near the distal end of the surgical device. The cannulaalso includes at least one expandable mechanism to distract the adjacentvertebrae when an implant material passes therethrough.

In one embodiment, the surgical device includes an inner memberreciprocable within the barrel. The inner member has features located onat least one outer surface of the inner member for engaging the first,second, third and fourth slots to expand the operative end of thebarrel. In another embodiment, the inner member is a rod. The innermember features comprise one or more contours on the outer surfaces ofthe rod. In yet another embodiment, movement of the inner member in adirection towards the operative end forces the operative end of thebarrel to expand. The barrel may further include one or more stops formaintaining the features of the inner member in a desired position alongthe length of the elongated barrel.

One having skill in the art will appreciate that embodiments of thepresent disclosure may have various sizes. The sizes of the variouselements of embodiments of the present disclosure may be sized based onvarious factors including, for example, the anatomy of the patient, theperson or other device operating with or otherwise using the apparatus,the surgical site location, physical features of the devices andinstruments used with the devices described herein, including, forexample, width, length and thickness, and the size of the surgicalapparatus.

One having skill in the art will appreciate that embodiments of thepresent disclosure may be constructed of materials known to provide, orpredictably manufactured to provide the various aspects of the presentdisclosure. These materials may include, for example, stainless steel,titanium alloy, aluminum alloy, chromium alloy, and other metals ormetal alloys. These materials may also include, for example, PEEK,carbon fiber, ABS plastic, polyurethane, polyethylene, photo-polymers,resins, particularly fiber-encased resinous materials rubber, latex,synthetic rubber, synthetic materials, polymers, and natural materials.

One having skill in the art will appreciate that embodiments of thepresent disclosure may be used in conjunction devices that employautomated or semi-automated manipulation.

The Summary of the Invention is neither intended nor should it beconstrued as being representative of the full extent and scope of thepresent disclosure. The present disclosure is set forth in variouslevels of detail in the Summary of the Invention as well as in theattached drawings and the Detailed Description of the Invention and nolimitation as to the scope of the present disclosure is intended byeither the inclusion or non-inclusion of elements, components, etc. inthis Summary of the Invention. Additional aspects of the presentdisclosure will become more readily apparent from the DetailedDescription, particularly when taken together with the drawings.

The phrases “at least one,” “one or more,” and “and/or,” as used herein,are open-ended expressions that are both conjunctive and disjunctive inoperation. For example, each of the expressions “at least one of A, Band C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “oneor more of A, B, or C,” and “A, B, and/or C” means A alone, B alone, Calone, A and B together, A and C together, B and C together, or A, B andC together.

Unless otherwise indicated, all numbers expressing quantities,dimensions, conditions, and so forth used in the specification andclaims are to be understood as being modified in all instances by theterm “about.”

The term “a” or “an” entity, as used herein, refers to one or more ofthat entity. As such, the terms “a” (or “an”), “one or more” and “atleast one” can be used interchangeably herein.

The use of “including,” “comprising,” or “having” and variations thereofherein is meant to encompass the items listed thereafter and equivalentsthereof as well as additional items. Accordingly, the terms “including,”“comprising,” or “having” and variations thereof can be usedinterchangeably herein.

It shall be understood that the term “means” as used herein shall begiven its broadest possible interpretation in accordance with 35 U.S.C.,Section 112(f). Accordingly, a claim incorporating the term “means”shall cover all structures, materials, or acts set forth herein, and allof the equivalents thereof. Further, the structures, materials, or actsand the equivalents thereof shall include all those described in theSummary of the Invention, Brief Description of the Drawings, DetailedDescription, Abstract, and Claims themselves.

The above-described benefits, embodiments, and/or characterizations arenot necessarily complete or exhaustive, and in particular, as to thepatentable subject matter disclosed herein. Other benefits, embodiments,and/or characterizations of the present disclosure are possibleutilizing, alone or in combination, as set forth above and/or describedin the accompanying figures and/or in the description herein below.However, the claims set forth herein below define the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of the specification, illustrate embodiments of the disclosure andtogether with the general description of the disclosure given above andthe detailed description of the drawings given below, serve to explainthe principles of the disclosures.

It should be understood that the drawings are not necessarily to scale.In certain instances, details that are not necessary for anunderstanding of the disclosure or that render other details difficultto perceive may have been omitted. It should be understood, of course,that the disclosure is not necessarily limited to the particularembodiments illustrated herein.

In the drawings:

FIG. 1 is a side elevational view of a first form of a surgical devicefor distracting adjacent vertebrae and inserting an intervertebral discimplant into an intervertebral space between the adjacent vertebrae, thedevice including an advancable rod for directing the implant received ina loading chamber through a cannula of the device, the rod being shownas broken to indicate length;

FIG. 2 is a cross-sectional view taken through the line 2-2 of FIG. 1showing the profile of an operative end portion of a barrel of thesurgical device, the device having been rotated 90 degrees from thefirst orientation of FIG. 1 to the second orientation of FIG. 2;

FIGS. 3 and 4 are enlarged fragmentary views of an alternate barrel forthe device showing an inner cannula, FIG. 3 showing the cannula havinglarger dimensions than the cannula shown in FIG. 4, the large dimensionportion of FIG. 3 being positioned within the device more rearwardlythan the smaller dimension portion of FIG. 4 so that advancement of arigid implant therethrough expands the barrel via the illustrated slots;

FIG. 5 is an enlarged fragmentary view of the operative end of FIG. 1showing a sheath or skirt, comprised of a stretchable, or elastomericmaterial, disposed thereon for protecting surrounding tissues;

FIG. 6 is an enlarged fragmentary view of a barrel of a second form of asurgical device, the barrel having slots cooperating with a wedgesformed on a second member to expand the slots and the barrel when thesecond member is retracted;

FIG. 7 is an enlarged fragmentary view of a portion of a form of thebarrel and second member of FIG. 6 the showing a stop for receiving thewedge, the stop formed on the slot;

FIG. 8 is an enlarged fragmentary view of a portion of a form of thebarrel and second member of FIG. 6 showing a stop, the stop formed onand between the slot and the wedge;

FIG. 9A shows a side perspective view of a surgical device according toone embodiment of the present disclosure;

FIG. 9B is a front perspective view of the surgical device of FIG. 9A;

FIG. 10A shows the surgical device of FIG. 9A in a first operativeposition;

FIG. 10B shows the surgical device of FIG. 9A in an intermediateoperative position

FIG. 10C shows the surgical device of FIG. 9A in a second operativeposition

FIG. 10D shows the surgical device of FIG. 9A including the devices ofFIG. 11A;

FIG. 11A shows a side elevation view of dilation rods for use with thesurgical device of FIG. 9A;

FIG. 11B is another side elevation view of the surgical device of FIG.9A and the dilation rods of FIG. 11A;

FIG. 11C is a front elevation view of the surgical device of FIG. 11B;

FIG. 12 is a side elevation view of the surgical device of FIG. 9Aincluding the device of FIG. 13A

FIG. 13A provides two top elevation views of an access portal accordingto one embodiment of the present disclosure, the access portalillustrated in both a first or closed position and a second or openposition;

FIG. 13B is a front perceptive view of the access portal of FIG. 13A;

FIG. 14 is a view of various components described in relation to FIGS.9A through 13B in an unassembled state;

FIG. 15 is a front perspective view of a surgical device according toyet another embodiment of the present disclosure;

FIG. 16A is a side elevation view of the surgical device of FIG. 15;

FIG. 16B is a detailed view of the surgical device of FIG. 16A;

FIG. 16C is a side elevation view of the surgical device of FIG. 16A ina second position;

FIG. 16D shows a detailed view of the surgical device of FIG. 16C;

FIG. 17A is a top plan view of the surgical device of FIG. 15;

FIG. 17B is a top plan view of the surgical device of FIG. 15;

FIG. 17C is a front elevation view of the surgical device of FIG. 15,corresponding to a second position as shown in FIG. 16C;

FIG. 17D is a detailed, front elevation view of the surgical device ofFIG. 17C;

FIG. 18A is a side perspective view of the surgical device of FIG. 15including an implant material and implant material insertion instrument;

FIG. 18B is a side elevation view of the surgical device of FIG. 18A ina second position;

FIGS. 18C-D are side perspective views of the surgical device accordingto another embodiment of the present disclosure;

FIGS. 18E-F are detailed top perspective views of the surgical deviceaccording to another embodiment of the present disclosure;

FIGS. 18G-J are various views of the surgical device according to yetanother embodiment of the present disclosure;

FIGS. 18K-N are perspective views of an insertion rod for use with thesurgical devices according to one embodiment of the present disclosure;

FIG. 19 is a view of various components described in relation to FIGS.15 through 18B in an unassembled state;

FIG. 20A is a side perspective view of a surgical device according toyet another embodiment of the present disclosure;

FIG. 20B is a front perspective view of the surgical device of FIG. 20A;

FIG. 21A is a side perspective view of the surgical device of FIG. 20A;

FIG. 21B is a detailed view of the surgical device of FIG. 21A;

FIG. 21C is a side perspective view of the surgical device of FIG. 21Ain a first position;

FIG. 21D is a side perspective view of the surgical device of FIG. 21Ain a second position;

FIG. 22A shows a front perspective view of the ratcheting mechanism ofthe surgical device of FIG. 20A;

FIG. 22B shows a front elevation view of the ratcheting mechanism of thesurgical device of FIG. 20A in a first position;

FIG. 22C shows a front elevation view of the ratcheting mechanism of thesurgical device of FIG. 20A in a second position;

FIG. 23A shows the ratcheting mechanism of FIG. 22A in a first position;

FIG. 23B shows the ratcheting mechanism of FIG. 22A in a secondposition;

FIG. 24 is a view of various components described in relation to FIGS.20A through 23B in an unassembled state;

FIG. 25A is a side perspective view of a surgical device according toyet another embodiment of the present disclosure;

FIG. 25B is a rear elevation view of the surgical device of FIG. 25A;

FIG. 26A is a side perspective view of the surgical device of FIG. 25A;

FIG. 26B is another side perspective view of the surgical device of FIG.25A;

FIG. 26C is a detailed view of the ratcheting mechanism of the surgicaldevice of FIG. 25A;

FIGS. 27A-C show partially exploded views of the ratcheting mechanism ofFIG. 26C;

FIG. 28 is a view of various components described in relation to FIGS.25A through 27C in an unassembled state;

FIG. 29A is a perspective view of a surgical site for use with thesurgical device of FIGS. 30-34;

FIG. 29B is a perspective view of the surgical site of FIG. 29A with aportion of the boney anatomy dissected to permit insertion of thesurgical device of FIGS. 30-34.

FIG. 30A is a front perspective view of a surgical device according toyet another embodiment of the present disclosure;

FIG. 30B is a front perspective view of the access port of the surgicaldevice of FIG. 29A;

FIG. 31A is a side perspective view of the surgical device of FIG. 29A;

FIG. 31B is a side elevation view of the surgical device of FIG. 30A;

FIG. 31C is a rear elevation view of the surgical device of FIG. 29A ina first position of use;

FIG. 31D is a rear elevation view of the surgical device of FIG. 29A ina second position of use;

FIG. 32A is a side elevation view of the access port of FIG. 29B in afirst position of use;

FIG. 32B is a side elevation view of the access port of FIG. 29B in asecond position of use;

FIG. 33A is a detailed perspective view of the surgical device of FIG.29A;

FIG. 33B is another detailed perspective view of the surgical device ofFIG. 29B;

FIG. 34 is a view of various components described in relation to FIGS.29A through 33B in an unassembled state;

FIG. 35A is a side perspective view of a surgical device according toyet another embodiment of the present disclosure;

FIG. 35B is a rear elevation view of the surgical device of FIG. 35A;

FIG. 36A is a side perspective view of the surgical device of FIG. 35A;

FIG. 36B is another side perspective view of the surgical device of FIG.35A;

FIG. 36C is a detailed view of the surgical device of FIG. 36B;

FIG. 37A shows the surgical device and adjustment mechanism of FIG. 35Ain a detailed view;

FIG. 37B shows the surgical device and adjustment mechanism of FIG. 37Ain a second position;

FIG. 37C shows the surgical device and adjustment mechanism of FIG. 37Ain a third position;

FIG. 37D shows the adjustment mechanism of FIG. 37A with the barrelremoved;

FIG. 37E shows the adjustment mechanism of FIG. 37D in a secondposition;

FIG. 37F shows the adjustment mechanism in a third position;

FIG. 38 is a view of various components described in relation to FIGS.35A through 37F in an unassembled state;

FIG. 39 is a perspective view of a surgical device according to stillanother embodiment of the present disclosure with the surgical device ina disassembled state;

FIG. 40 is an expanded perspective view of an embodiment of a cannula ofthe surgical device of FIG. 39;

FIG. 41 shows expanded perspective views of two embodiments ofdistractors of the surgical device of FIG. 39;

FIG. 42 is an enlarged perspective view of an embodiment of an expansiontube of the surgical device of FIG. 39;

FIGS. 43A, 43B are perspective views of the surgical device of FIG. 39illustrating insertion of the distractor into the cannula causing amovement of distractor places of the cannula;

FIGS. 44A, 44B are perspective views of the surgical device of FIG. 43Billustrating the expansion tube being inserted into the cannula bore,forcing the distractor blocks of the distractor to move radiallyoutwardly;

FIG. 45 is a perspective view of the surgical device of FIG. 44B afterthe surgical device has been rotated axially approximately 90 degrees;

FIG. 46 is a top plan view of a surgical device in an insertionconfiguration according to one embodiment of the present disclosure;

FIG. 47 is another top plan view of the surgical device of FIG. 46 in asecond configuration;

FIG. 48 is a perspective view of the surgical device of FIG. 46 in thesecond configuration;

FIG. 49 is another top plan view of the surgical device of FIG. 46 in adeployed configuration;

FIG. 50 is another top plan view of the surgical device of FIG. 46

FIG. 51 is a perspective view of the surgical device of FIG. 46;

FIG. 52 is a detailed view of a portion of the surgical device of FIG.51 illustrating a fixture device used to secure the adjustable armaturesagainst inadvertent movement;

FIG. 53 is a perspective view of a surgical device according to theembodiment described in relation to FIGS. 46-52 positioned against avertebral body;

FIG. 54 is a top plan view of a surgical device according to analternate embodiment of the present disclosure, the device being in aninsertion configuration;

FIG. 55 is a top plan view of the surgical device of FIG. 54 in adeployed configuration;

FIGS. 56A-C are top plan views of the surgical device of FIG. 46 indifferent positions of use;

FIGS. 56D-F are top plan views of the surgical device of FIG. 54 indifferent positions of use

FIG. 57 is a top plan view of a surgical device according to yet anotheralternate embodiment of the present disclosure, the device being in aninsertion configuration;

FIG. 58 is a front perspective view of the surgical device of FIG. 57;

FIG. 59 is another top plan view of the surgical device of FIG. 57 in adeployed configuration;

FIG. 60 is front perspective view of the surgical device of FIG. 57 inthe deployed configuration;

FIG. 61 is a top plan view of a surgical device in an insertionconfiguration according to yet another alternate embodiment of thepresent disclosure;

FIG. 62 is a front perspective view of the surgical device of FIG. 61;

FIG. 63 is another top plan view of the surgical device of FIG. 61 withthe surgical device in the deployed configuration;

FIG. 64 is front perspective view of the surgical device of FIG. 61 inthe deployed configuration;

FIG. 65A-B are various views of a surgical device according to yetanother alternate embodiment of the present disclosure with the surgicaldevice in a first configuration;

FIG. 65C is a side elevation view of the surgical device of FIG. 65A;

FIG. 65D is a top plan view of the surgical device of FIG. 65A in asecond configuration;

FIG. 65E is a view of the surgical device of FIG. 65A in the secondconfiguration positioned against a vertebral body;

FIGS. 66A-B are top plan views of a surgical device according to yetanother alternate embodiment of the present disclosure;

FIGS. 66C-D are views of the surgical device of FIG. 66A-B in useagainst a vertebral body;

FIG. 67A-D are various views of a surgical device according to yetanother alternate embodiment of the present disclosure, including a viewof the surgical device positioned against a vertebral body;

FIG. 68A-D are various views of a surgical device according to yetanother alternate embodiment of the present disclosure;

FIG. 69A-B are plan and perspective views of a surgical device accordingto yet another alternate embodiment of the present disclosure;

FIG. 70A-B are plan and perspective views of a surgical device accordingto yet another alternate embodiment of the present disclosure;

FIG. 71A-B are plan and perspective views of a surgical device accordingto yet another alternate embodiment of the present disclosure;

FIG. 72A-B are plan and perspective views of a surgical device accordingto yet another alternate embodiment of the present disclosure;

FIGS. 73A-C are perspective views of still another surgical deviceaccording to another embodiment of the present invention;

FIGS. 74A-F are various perspective and plan views of a surgical deviceaccording to yet another alternate embodiment of the present disclosure;

FIGS. 75A-D are various perspective and plan views of another surgicaldevice according to an embodiment of the present invention;

Similar components and/or features may have the same reference number.Components of the same type may be distinguished by a letter followingthe reference number. If only the reference number is used, thedescription is applicable to any one of the similar components havingthe same reference number.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent invention, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the invention is intended thereby. Any alterations andfurther modification in the described processes, systems, or devices,and any further applications of the principles of the invention asdescribed herein are contemplated as would normally occur to one skilledin the art to which the invention relates.

By way of example but not limitation, the present disclosure will bedescribed most often in connection with a minimally-invasive approach tothe disc space, such as by way of example a transforaminal approach.However, it is expressly understood that with any of the approachesdescribed in the Summary above, it is often difficult to prepare theproper locations in the disc space to receive an implant. In addition,another difficulty in these different approaches to the disc space isachieving proper positioning of the implant, particularly in the portionof the disc space most distal from the access portal when placing theimplant via a minimally-invasive approach. While it is desirable thatthe implant be ideally positioned in the disc space, it is often toodifficult to move the implant across the disc space or within the discspace once the implant is inserted. Thus, the present disclosure shouldbe understood as having utility across a number of different approachesto the disc space. Furthermore, the present disclosure should not beviewed as having utility limited to a human patient's spine.

As shown in FIGS. 1-75, and described in further detail herein, thepresent disclosure relates to novel surgical devices, such as animplants and an insertion devices for distracting two or more anatomicalfeatures and inserting the surgical device. In one embodiment, theimplant is adjustable to provide a surgeon with at least one first,deployable orientation and at least one second, stabilizing orientation,which is different from the first orientation. The adjustable surgicaldevices described herein provide an advantage over the prior art, inparticular by providing one or more adjustable features for maximizingthe effectiveness of the surgical device, which in turn reduces thelikelihood of misalignment, misplacement and subsequent mistake duringthe surgical procedure(s). A system and method for delivery of the novelimplants described herein is also disclosed.

Referring now to FIG. 1, a surgical device 10 is illustrated fordistraction of adjacent vertebrae and implantation of artificialintervertebral implants, including any of the surgical devices describedbelow in conjunction with FIGS. 46-75. The surgical device 10 may bedescribed as both a distractor and as an implantor; for convenienceherein, the surgical device 10 is referred to as an IDD 10. In use, aleading or operative end 12 of the IDD 10 is initially inserted betweenadjacent vertebrae in a first orientation, the IDD 10 then being rotatedto a second orientation to fully distract the vertebrae for receiving animplant therebetween. One or more implants are loaded into a centralcannula 14 of the IDD 10 and then forcibly advanced through the cannula14, out from the operative end 12, and into the intervertebral space.

In greater detail, a form of the IDD 10 includes an elongated insertionand distraction portion referred to herein as a barrel 20 having theoperative end 12 distally located from a stock end 22. The barrel 20includes a loading chamber 24 which includes an opening 26 extendingfrom the cannula 14 through the barrel 20 to the environment so that oneor more implants may be inserted through the opening 26 and into thecannula 14.

The cannula 14 extends the entire length of the barrel 20. At the stockend 22, a rod 30 is disposed. The rod 30 may, in one use, be viewed as apush rod; however, a distal end 30 a of the rod 30 may be connected witha dummy or trial device, such as a sizer, so that the trial device isinserted into the intervertebral space to determine a proper size for asubsequently-inserted implant, in which case the rod 30 would also pullin order to remove the trial device. The rod 30 may also consist of aplurality of rods (not shown), some or all of which may penetrate theimplant or implants, partially or completely.

These rods may move independently of one another, and to varyingdegrees, and may contact one or all components of a multi-componentimplant or a plurality of implants. The rod distal end 30 a may also beadapted to manipulate implants. For example, in one embodiment of thepresent invention, the rod 30 is operable to manipulate the adjustablearmatures of surgical devices to a deployed configuration as describedin more detail below in conjunction with FIGS. 46-75. The rod 30 mayalso interconnect with an engaging portions 720, 1120 of implants(illustrated in FIGS. 51, 65) to manipulate the implant or alter theconfiguration of the implant.

The distal end 30 a of the rod may also be used to rotate threadedfixtures, such as screws. In another example, the rod 30 is adapted tomanipulate a lock of a surgical device to fix an implanted surgicaldevice in a configuration determined by a surgeon. The rod 30 mayintroduce or manipulate a screw or other connection member to fix thesurgical device in the determined configuration. In another embodiment,the rod distal end 30 a includes a grasping feature adapted to bend orreshape portions of implants, including armatures of the implants.

Thus, the rod 30 (or rods) may also serve as a guide mechanism for theimplant(s) thru the cannula 14, and beyond the barrel 20, and into theintervertebral space, to a predetermined location, for predicabledeployment, as well as enable assembly of the of the implant(s) andcomponents into a final construct in the intervertebral space.

The loading chamber 24 allows access to the rod distal end 30 a when therod is in an at least partially retracted or withdrawn position. As anexample, the rod distal end 30 a may be threaded so as to be receivedwithin internal threads of an implant.

In another form, the rod 30 may be removed to allow a second rod orplunger (not shown) to be used for, as an example, a sizer or atargeting device. The targeting device may have a geometry matching orclosely approximating that of the implants to be used. Use of thetargeting device allows the user to manually and tactilely determine theshape (including contours) of the intervertebral size, as well as assessand select alignment of the IDD 10 with the vertebrae and intervertebralspace. The second rod may provide a depth gauge, such as graduated orother depth markings, enabling a surgeon to determine the depth at whichthe implant should be inserted. In the subsequent implant insertion, thesurgeon can operate the rod 30 to the same depth, or at least onedetermined based upon the use of the targeting device. Towards that end,the rod 30 may have graduated markings identical, similar, orcorresponding to those of the second rod.

Accordingly, the rod 30 reciprocates to and between advanced andretracted/withdrawn positions within the cannula 14. The rod 30 may bewithdrawn to be clear of the loading chamber 24, thus permitting animplant to be deposited into the loading chamber 24. The rod 30 may thenbe advanced or extended to a position so that the implant is forcedbeyond the barrel operative end 12 and, thus, inserted into theintervertebral space.

A distal section 40 of the barrel 20, including the operative end 12, isused for distraction of the adjacent vertebrae. A terminal portion 42 ofthe operative end 12 of the barrel distal section 40 has a reduceddimension to allow a portion thereof to be received between the adjacentvertebrae. More specifically, the operative end 12 includes a majordimension 44 extending in a first direction and a minor dimension 46extending in a second direction. During initial insertion of the IDD 10and, specifically, of the terminal portion 42 between the vertebrae, themajor dimension 44 is aligned laterally and generally parallel to thegeneral plane of the natural disc and intervertebral space (which isgenerally horizontal in an erect human, transverse to the longitudinalextent of the spine). The distal section 40 of the barrel 20 includeslongitudinal slots 70. The slots 70 allow the distal section 40 to becompressed during the initial insertion.

After initial insertion of the terminal portion 42, the user thenproceeds to force vertebral distraction. The user may apply an axialforce along the longitudinal direction, thus utilizing a wedge orchamfer 42 a formed on the terminal portion 42 to provide an initialdistraction amount.

Regardless, the user rotates the terminal portion 42 to causedistraction of the adjacent vertebrae. Generally speaking, the entireIDD 10 is rotated so that the major dimension 44 of the operative end 12is shifted from the first orientation generally aligned with the smallintervertebral space to a second orientation to be aligned with thesuperior-inferior longitudinal spinal axis (rostral-caudal). Thismovement necessarily forces the adjacent vertebrae apart, the outersurface 42 b (such as radiused corners illustrated in FIG. 2) of theterminal portion 42 acting as a cam surface. In the preferred form,minor sides 50 of the terminal portion 42 are shaped so that thecompression exerted on the minor sides 50 by the adjacent vertebraemaintains the terminal portion 42 in position in the second orientationand, more broadly, so that the entire IDD 10 is maintained with themajor dimension 44 aligned with the longitudinal direction of the spine.

It is also preferred that the terminal portion 42 includes stops 60formed on the terminal portion 42. In a first form, the stops 60 areformed as shoulders 62 on major sides 52 to limit the amount ofinsertion of the IDD 10 between the vertebrae. The stops 60 provide apredetermined position relative to at least sides of the vertebrae and,more preferably, a predetermined position relative to the intervertebralspace. More specifically, with a knowledge of the intervertebraldimensions and contours, and a knowledge of the size and shape of thevertebrae, the IDD 10 can be placed at a specific and known locationrelative to those features via use of the stops 60. As such, a user isable to insert an implant in a specific spot within the intervertebralspace. In a further form, stops 60 may also be formed as shoulders 64 onthe minor sides 50. The stops 60 may be formed on a selectivelypositionable member (not shown) so that a user may adjust the positionof the stops relative to the ultimate tip of the terminal portion, orposition the angle of the stops 60 relative to the longitudinal axis ofthe cannula 14 allowing the stops 60 to accommodate the vertebral aspectshape.

After rotation of the terminal portion 42, the IDD 10 may be operated toadvance an implant through the cannula 14 and into the intervertebralspace. It should be noted that, should a user desire, the cannula 14 maybe used to perform all modes of disc space preparation, such as adiscectomy or nucleotomy or for a trial or sizing device, for instance,and as a minimally invasive surgical technique.

The cannula 14 may have a uniform shape or non-uniform shape in both thelongitudinal direction and in cross-section. For instance, the rod 30may be closely fit through a proximal section 14 a of the cannula 14,thus serving as a guide to control the reciprocation of the rod 30. Acannula distal section 14 b may have a different size or cross-sectionalshape from that of the proximal section 14 a so that the rod 30 passeseasily therethrough.

In the preferred form, the distal section 14 b has a cross-sectionalshape corresponding to the shape of an implant. This cross-sectionalsurface shape may include additional features or projections, such asribs or rails, that further guide or orient the implant into apredetermined position. As can be seen in FIG. 2, one form of thecannula 14 has a rectangular cross-sectional shape for use with animplant of similar or identical cross-sectional shape.

Notably, the cross-sectional shape of the distal section 14 bcorresponds to, but need not be identical to, the cross-sectional shapeof an implant. In use, once the terminal portion 42 has been rotated todistract the vertebrae, the cannula distal section 14 b may taperinwardly, prior to the implant being advanced through the cannula distalsection 14 b by the rod 30. In this position, the terminal portion 42generally remains in the somewhat compressed state due to the insertionand distraction process, both in the direction of the minor dimension 44as friction and pressure between the terminal portion 42 and thevertebral endplates does not generally permit normal, elastic return toa natural position, and in the direction of the major dimension as thevertebrae exert a compressive force on the minor sides 50.

The distal section 14 b is expanded by the advancing implant. As theimplant is forced through the distal section 14 b by the rod 30, themajor sides 52 are forced laterally outwardly. In some forms, the minorsides 50 are also forced outwardly (superior-inferior direction,rostral-caudal direction) to provide additional distraction. Again,expansion and contraction of the distal section 14 b is permitted by theslots 70.

As described, the distal section 14 b acts somewhat as a guide rail.Discussed above, the stops 60 provide a user with a known orascertainable starting position, relative to the vertebrae. Theclose-fit and co-operation of the distal section 14 b with the implantshape allow a user to have a definite knowledge of where and in whatorientation the implant exits the cannula 14. Again, the use of theabove-described targeting device/sizer and/or graduated markings on therod 30 also help the user locate the implant at a known position.

After the initial implant or implant component has exited from thedistal section 14 b and into intervertebral space, a multitude ofsubsequent components may be delivered into the intervertebral space ina similar fashion, trailing the initial component, and forcibly driventogether into a final assembly by the rod 30 or rods. Throughout thissequential process, the distal section 14 b is ready for furtherimplants or implant material. The distal section 14 b likely compressessomewhat in the rostral-caudal direction (shortening the major dimension44 by compressing the slots 70 thereof). The distal section 14 b may ormay not compress in the lateral direction (e.g., for shortening theminor dimension 46) due to residual force thereon from the endplates.The rod 30 or rods may be retracted or withdrawn so that its leading endis clear of the loading chamber 24 and received in the cannula proximalsection 14 a. A subsequent implant or implant material may then beloaded into the loading chamber 24 for advancement into theintervertebral space via a second advancement of the rod 30. Such allowsadditional implantation without requiring removal or re-insertion of theIDD 10, in contrast to other known devices described, for example, inU.S. Pat. Nos. 3,486,505 and 6,368,325 and U.S. Patent ApplicationPublication No. 2008/0161817, which are each incorporated herein intheir entirety. Furthermore, the placement of multiple implantcomponents in the chamber, placed one behind the other, or placedside-by-side, allows the rod 30 or rods to deliver implants to theintervertebral space in a simultaneous and or sequential fashion. Forinstance, implants that are constructed of simultaneously orsequentially inserted components or adjustable components areadvantageously accommodated by the IDD 10, as well as fusion proceduresin which graft material may be subsequently packed into theintervertebral space and/or into cavities formed in and around theimplant itself.

The IDD 10 is designed to protect, or avoid, adjacent tissues includingneural tissues. Prior to and during initial insertion of the IDD 10, asheath or skirt 77 is positioned around the terminal portion 42. Theskirt 77 prevents or limits the ability for tissues to be caught by theslots 70 or the stops 60. In various exemplary forms, the skirt 77 maythen be retracted to expose the slots 70 and stops 60, and/or the skirt77 may be positioned to extend rearwardly from the stops 60 or simplyexpand to accommodate the expansion of the slots 70 when an implant isadvanced through the distal section 14 b of the cannula 14.

As illustrated, the IDD 10 is operated in a pistol-trigger fashion,though a rotating knob (not shown) or other actuator type may beemployed. As can be seen in FIG. 1, the barrel 20 is supported by andsecured with a grip 80. The grip 80 allows the user to manipulate theIDD 10 generally with a single hand. A trigger 82 is hinged with thegrip 80 and is spring-biased so that an actuator end 82 a anglesdownwardly and away from the grip 80. When the trigger 82 is actuated bya user, the actuator end 82 a is pulled (such as by fingers of thesingle hand) towards the grip 80, an upper, rod end 82 b of the trigger82 moving forwardly toward the operative end 12 of the IDD 10. The rodend 82 b contacts or mates with the rod 30 to incrementally advance therod 30 and an implant in the cannula distal section 14 b or loadingchamber 24.

Initial advancement of the rod 30 may be manually, such as by simplyforcing the rod 30 forward by applying force to the end thereofprotruding from the barrel 20. Once force is required, the trigger 82may be employed. The engagement between the trigger rod end 82 b and therod 30 is such to permit slipping therebetween when the rod 30 is beingadvanced forward relative to the trigger 82. In one form, the triggerrod end 82 b and the rod 30 may frictionally engage, while in anotherform the rod 30 may have a series of notches (not shown) that act in aratchet manner with the trigger rod end 82 b, though other mechanismsmay be employed.

In a preferred form, the IDD 10 is easily cleaned and sterilized. Tofacilitate removal of particulate matter, the IDD 10 may be disassembledby removing a pivot pin 84 for the trigger 82 and removing the barrel 20from the grip 80. The rod 30 may also be removable through the cannulaproximal section 14 a and the skirt 77 being removable from either endof the barrel 20.

The implants may be any type of partial or total disc replacementimplant, and may be any type of implant such as natural or artificialbone graft material, fusion boxes or cages, expandable devices,sequentially-constructed devices, hydrogel- or hydrophilic-baseddevices, or others made of metallic, polymeric, elastomeric, ceramic,materials, or combinations of these types.

In one form, the IDD 10 may be secured with a spinal fixation systemsuch as a pedicle screw installed on a vertebrae prior to use of the IDD10. This promotes maintaining the IDD 10 in the selected and desiredposition determined by the user during use of the trial or targetingdevices, discussed above, for instance.

It should be noted that the operative end 12 and terminal portion 42 mayhave a variety of exterior or surface configurations. The terminalportion 42 has been illustrated and impliedly discussed as beinggenerally rectangular, as shown for FIG. 1. Beyond this, the preferredform has, at minimum, radiused corners 53 to facilitate rotation of theterminal portion 42 between and against the vertebrae. In various forms,the corners 53 need not be identical, such as by providing a singledirection of rotation for the terminal portion 42. Moreover, the majorand minor dimensions 44, 46, and their respective sides, may also beviewed as corresponding to a racetrack-shape having curved or circularminor sides connected by straight sides, or may be viewed as an oval orelliptical having major and minor axes, as mere examples. As illustratedin

FIGS. 3 and 4, an alternate form of a barrel 20′ may have a circular orcylindrical outer surface 21′, with a rectangular cross-section forcannula distal section 14 b′ that varies from a larger size (FIG. 3)proximal the loading chamber 24 to a smaller size (FIG. 4) closer to orat the terminal portion 42.

A second form of an inserter/distractor device or IDD 100 is illustratedin FIG. 6. In simple terms, the IDD 100 has a small dimensioned profileor leading portion 110 for initial insertion between adjacent vertebrae.Unlike the above-discussed IDD 10, however, the IDD 100 is not rotated,instead operating to expand and distract the vertebrae by relativeshifting of two components.

In the illustrated form, the IDD 100 includes an outer member 120somewhat in the form of a sleeve having a cannula 122. The outer member120 may include stops 60 for providing a predetermined or known positionrelative to the vertebrae. A leading end 124 is positioned between thevertebrae, up to the stops 60. After the initial insertion of theleading end, an inner member 130 is moved relative to the outer member120 to expand the outer member 120. More specifically, the outer member120 is illustrated as having a somewhat quadrilateral shape, similar tothat of IDD 10, with rostral-caudal sides 126 corresponding to a lateraldimension (into the plane of FIG. 6) and having lateral sides 128corresponding to a rostral-caudal dimension 129. When expanded, thedistance between the rostral-caudal sides 126 (across the cannula 122)are increased, increasing the rostral-caudal dimension 129. At leasteach of the lateral sides 128 includes a longitudinally extending slot121 that permits such expansion. In other forms, a plurality of slots(not shown) may be provided on the outer member 120, such as slots (notshown) on the rostral-caudal sides 126 and additional slots (not shown)on the lateral sides, each of these other slots allowing for additionalexpansion due to an implant passing therethrough, as is described abovefor the IDD 10. A skirt 77 (FIG. 5) may also be provided.

In the illustrated form, the inner member 130 is a partial sleeve,having a sleeve-like body portion 132 closely received within the outersleeve cannula 122 and having forwardly or distally extending arms 134.The arms 134 each have a small wedge 136 facing outward and engaged inrespective minor side slots 121, which themselves may have angledsurfaces 121 a as shown in FIG. 6. As the inner member 130 is retracted,the wedges 136 are forced rearwardly through the slots 121, thusexpanding the slots 121 and the minor sides 128 so that the major sides126 are moved apart to distract the vertebrae.

There are a number of variations on the IDD 100. For instance, theshapes of the wedge 136 and slot 121 could be reversed so that advancingthe inner member 130 (as opposed retracting, as discussed) forces theslots 121 to widen. The inner member 130 may be simply the pair of arms134, without the body portion 132, or the body portion may be some othertype of bridge allowing the arms 134 to be manipulated jointly. Inanother form, the inner member 130 may be entirely sleeve-like throughthe portion of the IDD 100 that the implant would pass, but for thewedges 136 protruding therefrom. In another form, the rod 30 may beconnected to the inner member 130 so that, either prior to or incombination with the implant reaching the distal-most portion of the IDD100, movement of the rod 30 causes the wedges 136 to shift and widen theslots 121 to expand the IDD 100.

These forms of the IDD 100 have distinct benefits over the prior art.For instance, the construction of the IDD 100 minimizes the amount ofdistraction that is necessary for an implant to pass therethrough. Asthe wedges 136 are to the lateral sides 128 (in the lateral direction),the amount of rostral-caudal distraction need not accommodate the wedges136 nor, in a number of described forms, the inner member 130. This isin contrast to the design of the distractor/implantor illustrated byU.S. Patent Application Publication No. 2007/0270875, to Bacher, et al,which is incorporated by reference herein in its entirety. Thedistractor/implantor described by Bacher requires a significant amountof distraction simply to allow the distractor components to remainbetween the vertebrae as the implant passes therethrough. Movement ofthe wedges 136 can also be calibrated so that a particular amount ofretraction of the inner member 130 corresponds to a known amount ofdistraction.

In some forms, the slots 121 and wedges 136 may cooperate to form stops150 for maintaining the wedges 136 in a desired position. FIG. 7illustrates a stop 150 in the form of small barbs 152 that the wedge 136passes beyond when being retracted. The wedge 136 is thus unlikely toinadvertently slip or return over the barbs 152 during use of the IDD100, that is, without a user intentionally forcing the wedge 136 overthe barbs 152.

FIG. 8 illustrates a stop 150 in another form, specifically flatportions 154 formed on the surfaces of the slot 121 and flat portions156 formed on the wedges 136. When the wedges 136 reach the slot flats154, the pressure on the wedges 136 that would tend to expel the wedges136 therefrom is reduced or even eliminated, with simply a compressiveforce on the wedges 136. While the wedge flats 156 are not required,they assist with movement of the wedges 136 against the slot flats 154,as the wedges 136 may otherwise bite into or grind against the slots121. Although not shown, edges of the wedges 136 may be rounded so thatthe inner member 130 and wedges 136 may be rotated relative to the slots121 and outer member 120 in order to release the wedges 136 from theslots 121 and, more particularly, quickly release the stops 150.

It should also be noted that the slots 121 may have a varying contourfor more controlled distraction. That is, as the distraction at thedistal-most end of the IDD 100 is based on an angular opening of theslots 121, the geometry of the wedges 136 and slots 121 may be designedso that equal amounts of movement of the wedges 136 along the slotsresults in equal amounts of gross distraction for the IDD 100.

According to another embodiment of the present disclosure, a surgicaldevice 200 is shown in FIGS. 9A and 9B. In certain embodiments, thesurgical device 200 may be used to facilitate distraction of the laminararch of a patient. FIG. 9A shows the surgical device 200 in a sideperspective view. According to this embodiment, the surgical device 200includes a grip 280 and trigger 282 which are configured to manipulateratcheting mechanism 270 and thereby position ratchet elements 273, 275in an engaged or disengaged position against rod 230. In FIG. 9A,ratcheting elements 273, 275 are shown in the engaged position and arepositioned against an outer surface of rod 230. Rod 230 is preferablyconfigured to be received within an opening 226 of barrel 220, asdescribed in various embodiments herein. In one embodiment of thepresent invention, the barrel 220 is comprised of two sections 220 a and220 b. Barrel sections 220 a and 220 b may further comprisecorresponding and partially overlapping surfaces to permit section 220 ato be substantially congruent with 220 b, or to permit separation ofsection 220 a from 220 b, as explained in further detail below.

Referring now to FIG. 9B, the surgical device 200 is shown in a frontperspective view. An opening 226 extends substantially through barrelsection 220 a and 220 b and may permit one or more implant materials tobe inserted therethrough. According to this embodiment, operation oftrigger 282 may be accomplished by a user as described above, wherebysqueezing trigger 282 against grip 280 operates ratcheting mechanism 270and advances rod 230 in a generally longitudinal direction relative tobarrel 220.

According to one embodiment, the advancement of rod 230 in barrel 220causes distraction of barrel. The use of ratcheting mechanism 270permits the advancement of rod 230 to occur in a sequential andpredetermined manner. In one embodiment, rod 230 may be tapered toachieve the desired level of distraction and the predetermined stages ofadvancement within barrel 220. In one embodiment, ratchet elements 273,275 are operable by use of trigger 282 and serve in part to secure rod230 in the proper location relative to barrel for each sequential stageof advancement. In another embodiment, the ratchet elements 273, 275 maybe selectively engaged or released from the rod 230 at the user'spreference.

According to yet another embodiment, the rod 230 may be substituted withmultiple rods or dilators. In one embodiment, the dilators are taperedand cause distraction of barrel 220 as dilators are advanced into barrel220 as described above in relation to FIG. 9B. In varying embodiments,the rod or dilators may be substantially circular in cross-section, ormay be substantially oval-shaped, elliptical, rectangular, or othershapes including polygonal.

Various stages of advancement of rod 230 relative to barrel 220 areshown in FIGS. 10A-10D. FIG. 10A shows the surgical device 200 in afirst operative position with the rod 230 completely separated frombarrel 220. The use of trigger 282 in conjunction with ratchetingmechanism 270 provides a user with an easy to operate mechanical device,which does not require excessive force and provides distraction that ispredictable and repeatable. FIG. 10C shows another operative position,wherein rod 230 has been advanced within barrel 220. FIG. 10D shows thesurgical device 200 in an intermediate position wherein rod 230 ispartially advanced within barrel 220 and further comprises one or moreserial dilation rods 296, as described briefly above and in thefollowing paragraphs.

According to one embodiment, the surgical device may further include oneor more serial dilation rods, such as those shown in FIG. 11A. Accordingto this embodiment, the surgical device 200 may advance a first dilatingrod, followed by a second dilating rod, followed by a third dilatingrod, which are depicted in FIG. 11A as 292, 294 and 296. According toyet other embodiments, fewer or greater number of dilating rods may beemployed than shown in FIG. 11A.

Referring now to FIG. 11B, the surgical device 200 according to FIGS. 9Aand 9B is shown in a side elevation view with the serial dilators 292,294, 296 inserted within barrel 220. FIG. 11C shows a front elevationview of the surgical device 200 according to the embodiment of FIG. 11B.In operation, embodiments of the surgical device shown in FIGS. 11A-11Cpermit the user to advance various rods or dilators serially to permitprogressive distraction of barrel sections 220 a and 220 b. Once thedesired level of distraction of barrel sections 220 a and 220 b has beenaccomplished, the user may further insert a final stage rod or dilator,which according to one embodiment may be employed to establish an accessportal to the intervertebral space, by way of example. In thisembodiment, a final stage rod or dilator may also permit the serialdilators 292, 294, 296 to be removed from barrel 220. In certainembodiments, the level of distraction is not dependent on the diameterof the final serial dilator. In certain embodiments, the user may alsoobserve the level of advancement of the dilators within the surgicaldevice to maintain depth control.

Referring now to FIG. 12, one embodiment of the surgical device isshown, which comprises a selectively removable access portal 310. Accessportal 310 may be used with the surgical device 200 described above oraccording to any of the embodiments described herein. According to thisembodiment, once the series of dilators 292, 294, 296 have been insertedinto the barrel 220 of the surgical device 200 to achieve the desireddistraction, and the first and second serial dilators are removed, theaccess portal 310 may be inserted through the largest of the serialdilators 296. In other embodiments, the access portal may be insertedprior to the final serial dilator is removed. According to oneembodiment, the access portal 310 comprises a distal end 312 to maintainthe desired distraction between, for example, an intervertebral space,and further comprises an operative end 311 for manipulation of theaccess portal 310.

Referring now to FIGS. 13A and 13B, a top elevation view and a frontperspective view of the access portal 310 are shown, respectively.Referring in detail to FIG. 13A, the access portal 310 is shown in botha first or closed position (upper drawing) and a second or openedposition (lower drawing). In the closed position, access portal 310 isshown with the operative end 311 in a first position, which causes acorresponding slider 313 to be positioned near or adjacent the distalend 312. In the second or opened position, the access portal 310 has theoperative end 311 in a second position and a corresponding position ofthe slider 313 removed from the distal end 312, as shown in FIG. 13A.

According to one particular embodiment, the slider 313 may include aplurality of apertures, which permit the legs 315 of access portal 310to slide therethrough. In one embodiment, the legs 315 are pivotallyinterconnected to a linkage 317. Accordingly, as a user pushes or pullsoperative end 311 of access portal 310, the legs 315 are opened orclosed relative to the position of slider 313 about the longitudinalaxis of legs 315. In yet another embodiment, the access portal 310 maycomprise a collar or ring to maintain distraction although access portal310 may be removed or adjusted, for example, to achieve a differentdegree of distraction. In yet another embodiment, the access portal maybe actuated by an existing power supply as opposed to manually actuated.Further illustration of the access portal 310 is shown in connectionwith FIG. 13B and the components depicted in FIG. 14.

Referring in detail to FIG. 13B, the access portal 310 is shown in afront perspective view. The distal end 312 may be formed of any shape,size, or orientation, including but not limited to that shown in FIG.13B. According to one embodiment, the distal end 312 may include one ormore components which are selectively removable from the body of theaccess portal 310. According to one embodiment, the operative end 311may be pushed or pulled to operate the slider 313 relative to the legs315, and may further be rotated to permit removal of the distal end 312from the body of the access portal 310. A complete set of components ofthe access portal 310 may be seen in FIG. 14 in a disassembled state.

Referring now to FIGS. 15-19, another embodiment of a surgical device300 of the present disclosure is shown. According to this embodiment,the surgical device 300 comprises a cam mechanism 350 located on thedistal end of surgical device 300, which permits both distraction anddelivery of one or more implant materials through the barrel 320 of thesurgical device 300.

Referring in detail to FIG. 15, a front perspective view of the surgicaldevice 300 is shown. According to this embodiment, the cam mechanism 350is interconnected to a trigger 382, which is further coupled to grip380, and which are mechanically linked to achieve rotation of cammechanism 350, as described in greater detail below. A mechanicallinkage 390 preferably interconnects first cam section 392 a and secondcam section 392 b to slider 375, which is further connected to trigger382.

Referring now to FIGS. 16A and 16B, a side elevation view and detailedview of the surgical device 300 are shown, wherein the device is in afirst position. In this position, a user may insert the distal end ofthe surgical device barrel 320 into the operative site of a patient. Theuser may thereby position the cam mechanism 350, for example, betweentwo vertebrae. As shown in the detailed view of FIG. 16B, when thesurgical device is in a first position, the first cam section 392A andthe second cam section 392B (not visible in FIG. 16B) are substantiallyaligned. The linkage 390 between the trigger 382 and cam mechanism 350is also shown in a first position.

Referring to FIGS. 16C and 16D, the surgical device 300 is shown in asecond position. Referring in detail the detailed view FIG. 16D, thefirst cam section 392A has been rotated downwardly or in a generallyclockwise direction, and second cam section 392B has been rotatedupwardly or in a generally counterclockwise direction. This rotation iscaused by the trigger 382 being squeezed relative to grip 380, as shownin FIG. 16C. Depressing trigger 382 causes slider 375 to movelongitudinally, which in turn causes a corresponding movement to linkage390 in a general longitudinal direction. Movement of linkage 390 in turncauses pins 394 to move within slots 395, as best shown by comparingFIGS. 16B and 16D. This rotation of pins 394 within slots 395 causesrotation as shown in FIG. 16D of first cam section 392 a and second camsection 392 b, which increases the distraction between theintervertebral space.

Referring back to FIG. 15, the rotation of first and second cam section392 a, 392 b further causes aperture 326 to be positioned such that oneor more implant materials may be passed through barrel 320 and exitaperture 326. Thus, aperture 326 is aligned with the longitudinal accessof barrel 320 when first and second cam section 392 a, 392 b are in asecond position, as shown in FIGS. 16C, 16D. This step may be repeatedfor varying implant materials and corresponding varying levels ofdistraction.

Referring to FIGS. 17A and 17B, the surgical device 300 is shown in atop plan view. FIG. 17A shows the surgical device 300 in a firstposition, corresponding to the position shown in FIG. 16A. FIG. 17Bshows the surgical device 300 in a second position, corresponding toFIG. 16C. As with previously described surgical devices, surgical device300 permits incremental distraction, and may further permit bothdistraction and expansion. In one embodiment, this is achieved byproviding cooperating cam elements, which rotate to distract, and mayalso expand outwardly once distracted to expand the distal end of thesurgical device 300 in a lateral direction. In this manner, one or moreimplant materials of a larger size may be delivered through the distalend of surgical device 300, as will be understood from the followingdescription.

FIG. 17C shows the surgical device 300 in another front elevation view.FIG. 17D is a detailed view of the front elevation view of surgicaldevice 300, demonstrating how apertures 326 of first and second camsections 392 a and 392 b are aligned with barrel 320, and thereby permitone or more implant materials to be delivered therethrough. FIG. 17Dalso demonstrates how first cam section 392 a and second cam section 392b may be rotated to achieve greater distraction than when cam mechanism350 is in a first position, as shown in FIG. 16A.

FIG. 18A shows a side perspective view of the surgical device 300 ofFIG. 15, including an implant material and implant material insertioninstrument. FIG. 18B is another side elevation view of the surgicaldevice of FIG. 18A shown in a second position. According to certainembodiments, the operation of trigger 382 may actuate both rotationand/or expansion of cam sections 392 a and 392 b, but may also advancerod 399 within barrel 320. The rod 320 preferably comprises an operativeend 397 and a distal end 396, the distal end 396 capable of receivingone of several types of implants, including implant I as shown in FIG.18A as well as any of the implants described below in conjunction withFIGS. 46-75. In one embodiment, the actuation may cause the rod 399 toadvance longitudinally within barrel 320, and may cause rotation of rod399 to rotate an implant I through the surgical device 300 and into adesired orientation prior to delivery through the distal end of surgicaldevice 300. In certain embodiments, the advancement and/or rotation ofrod 399 may be achieved by a secondary trigger (not shown in FIGS.18A-B).

Rod 399 may further comprise one or more indicia (not shown) to allow auser to visually determine the depth or advancement of rod 399 withinbarrel 320. In other embodiments, the rod 399 may further comprise ribs,threading, or other surface irregularities that provide a hard stop,preventing advancement of rod 399 beyond a desired location. In yetother embodiments, the surface irregularities may further facilitaterotation of rod 399 within barrel 320, such as by providing a threadedsurface of rod 399 corresponding to a threaded interior surface ofbarrel 320.

FIGS. 18C-D include side perspective views of the surgical device 300according to another embodiment of the present disclosure. The surgicaldevice shown in FIGS. 18C-D comprises a plurality of notches 398 alongthe length of rod 399, which preferably assist in ratcheting of the rod399 through the longitudinal axis of barrel 320. According to apreferred embodiment, the ratcheting insertion of rod 399 may beaccomplished by use of a second trigger 382 b, which incrementallyadvances the rod 399 and thereby advances the position of an implant I.

FIGS. 18E-F are detailed top perspective views of the surgical device300 according to another embodiment of the present disclosure. In thisparticular embodiment, the plurality of notches 398 b are located alongan outer top surface of the frame of the surgical device, and facilitateselective placement of a stop 396. The stop 396 may be placed at thepreference of the user to prevent the operative end 397 from advancingpast the stop 396, as best shown in FIG. 18F.

FIGS. 18G-J depict various views of a surgical device 300 according toyet another embodiment of the present disclosure. In this embodiment, amodified rod 399 is provided comprising a first portion 399 b and asecond portion 399 c, which are configured to move relative to eachother in at least one plane. The surgical device of this embodimentincludes a plurality of notches 398 c along at least one surface of thebarrel 320 of the surgical device 300, as shown in FIG. 18H. Theplurality of notches 398 c allow a post 387 to be received within anyone of the notches and at a desired location along the longitudinallength of the barrel. The post is coupled to a movable arm 388, whichmay be oriented by rotating the post 387 within any one of the notches398 c, as best shown in FIG. 18H.

Referring now to FIGS. 18I-J, the arm 388 may be positioned to redirectsecond rod portion 399 c after implant I has advanced through the distalend of the barrel as shown in FIG. 18I. In one embodiment, the user mayrotate the post 387 either before or after the rod portions 399 b, 399 chave been advanced through the barrel of the surgical device. Accordingto at least one embodiment, the implant I may be connected to the distalend of second rod portion 399 c such that the implant I is free to pivotprior to being released from the second rod section 399 c, as shown inFIG. 18J.

FIGS. 18K-N are perspective views of an insertion rod for use with thesurgical devices according to one embodiment of the present disclosure.The rod 399 according to this embodiment comprises at least one internallumen, which may house one or more tines P1, P2 for coupling the rod 399to an implant I, such as the one shown in FIG. 18N. The rod 399 of thisembodiment may comprise a tip T which separates two tines P1, P2 as theyare advanced longitudinally from the rod 399 inner lumen. In oneembodiment, the tines are advanced by advancing the operative end 397 ofrod 399 within the inner lumen of the rod 399. In another embodiment,the tines P1, P2 may be manipulated by rotation of operative end 397relative to rod 399. Tines P1, P2 preferably comprise means forlatching, hooking, grasping or otherwise selectively attaching toimplant I.

In one embodiment, surgical device 300 may be comprised of a materialthat permits impaction on the operative end of the device, for examplewith a mallet. In another embodiment, the rod 399 has an operative end397 that is configured to receive an instrument to achieve delivery of acorresponding implant I, such as, but not limited to a mallet. Variousviews of components for the surgical device 300 according to thisembodiment are shown in an unassembled state in FIG. 19.

Referring now to FIGS. 20-24, another embodiment according to thepresent disclosure is shown. Referring in detail to FIG. 20A, a sideperspective view of a surgical device 400 is shown relative to adjacentvertebral bodies. Referring to FIG. 20B, a front perspective view of thesurgical device 400 is shown. The surgical device 400 according to thisembodiment comprises a barrel 410 with an aperture 426 therethrough,which facilitates insertion of one or more implant materials. Thesurgical device 400 also includes a ratcheting mechanism 420, whichpermits a level of mobility and/or distraction of the ratchetingmechanism at the operable end of the surgical device 400. As explainedin more detail below, the surgical device 400 comprises at least onegear 430 and a plurality of arms 442, 444 which are positioned onopposing sides of the barrel 410, and which may be selectivelypositioned against or attached to one or more screws 412, 413 insertedinto, for example, adjacent vertebral bodies.

The surgical device 400 preferably provides independent distraction oneach lateral side of the barrel 410. The positioning and manipulation ofarms 442, 444 also permits a user to adjust the location of the port (ordistal end of the aperture 426) laterally relative to the intervertebralspace shown in FIGS. 20A-B. As described in greater detail below, thebarrel 410 also permits a quick connection or disconnection from theratcheting mechanism 420, if desired.

Detailed views of the surgical device 400 are shown in FIGS. 21A-D.Referring now to FIG. 21A, a side perspective view of the surgicaldevice 400 is shown. Attention is drawn to the detailed section ofsurgical device 400, which is enlarged and depicted in FIG. 21B.Referring to FIG. 21B, the ratcheting mechanism 420 further comprises,according to a preferred embodiment, at least one gear 430, whichinterfaces with at least one linear gear element 431, which permitcorresponding leg 442 and coupling mechanism 443 to move laterally withrespect to ratcheting mechanism 420 during operation of the surgicaldevice 400. The ratcheting mechanism 420 permits varying height andlocation of the surgical device 400 relative to the surgical site, asmay be seen from comparison of FIGS. 22B and C.

Referring to FIG. 22A, a complete assembly of the ratcheting mechanism420 is shown in a front perspective view. According to this embodiment,the ratcheting mechanism 420 is comprised of a first adjustable element423 a and second adjustable element 423 b, which are in communicationwith the barrel 410 of surgical device 400. In this manner, adjustableelement 423 a and adjustable element 423 b may be manipulated by placingan item, such as cannula, dilator, instrument, tool or other item intothe aperture 426 of the barrel 410 and thereby expand the aperture 426.This placement in turn forces adjustable element 423 a and 423 blaterally apart, as will be best understood by viewing FIGS. 23A and23B. FIGS. 22B and C show the ratcheting mechanism 420 is a retractedand distracted position, respectively.

Referring to FIG. 23A, the ratcheting mechanism 420 is shown in a firstposition. The ratcheting mechanism 420 may further comprise one or morelock bars 432, which may be positioned to maintain the position of firstadjustable element 423 a and second adjustable element 423 b whenexpanded to the desired location.

Referring to FIG. 23B, the ratcheting mechanism 420 is shown in a secondposition, wherein the aperture 426 has been expanded. According to apreferred embodiment, the locking bar 432 may be a rotatable lock bar,and may be positioned between teeth of gear 430, as shown in FIG. 23B. Adepiction of the components of the surgical device 400 and ratchetingmechanism 420 are shown in an unassembled state in FIG. 24, including aratchet housing 421.

Referring now to FIGS. 25-28, an alternate embodiment from the onedescribed in relation to FIGS. 20-24 is shown. According to thisembodiment, the surgical device 400′ further comprises a grip 450, andmay further comprise a trigger for operating surgical device 400′.According to this embodiment, ratcheting mechanism 420′ may comprise aplurality of lock bars 432′ as shown in FIG. 27A-27C. FIGS. 26A-C depicta surgical device 400′ similar to the surgical device 400 describedabove, except the arms 442′ are fixed relative to the ratchetingmechanism 420′ to permit greater stability.

Various detailed views of the ratcheting mechanism 420′ according to oneembodiment are shown in FIGS. 27A-C. Accordingly, in at least oneembodiment, the lock bars 432′ shown in FIG. 27A-27C may further operateas a ratcheting mechanism within the housing of surgical device 400′,thereby maintaining the position of adjustable element 423 a andadjustable element 423 b relative to one another as they are expanded,as best shown in FIG. 27C. Release of the lock bars 432′ may beaccomplished by operating the trigger relative to the grip 450 ofsurgical device 400′. Various components of surgical device 400′ areshown in an unassembled state in FIG. 28. It is expressly understoodthat these components are not necessarily to scale.

Referring to FIGS. 29A-B, perspective views of one particular surgicalsite are shown. In FIG. 29A, the boney anatomy is shown unaltered. InFIG. 29B, the laminar arch has been dissected to create a portal orwindow for use with the surgical device described in varying embodimentsherein. The dissection of the laminar arch facilitates use of thesurgical device to distract adjacent boney anatomical structures, asdescribed and shown in relation to FIGS. 30-34.

According to another embodiment of the present disclosure, a surgicaldevice 500 may comprise a barrel 520 and an adjustment shaft 510, whichmay be used to achieve distraction between two adjacent pedicle screws511, 512. Referring now to FIGS. 30A and 30B, a front perspective viewof the surgical device 500 and associated components are shown accordingto one embodiment.

Referring to FIG. 30A, surgical device 500 may be positioned between twoadjacent vertebrae. The surgical device 500 preferably includes alongitudinal barrel 520, which has an extension for receiving anadjustment shaft 510, as shown in FIG. 30A. Surgical device 500 ismodular and may be used in connection with a variety of differentlyconfigured access ports, as described in the following detaileddescription.

Referring to FIG. 30B, certain embodiments of the surgical device 500further comprise an access port 530, which may be positioned betweenadjacent vertebrae (noted by adjacent pedicle screws 511 in eachvertebrae). According to further embodiments, the access port 530 mayfurther comprise a sleeve 540. The sleeve 540 may serve to protect fromdamage to surrounding neural elements or other anatomical features ofthe patient. In certain embodiments, the sleeve is made of an interwovenmesh, and is substantially deformable. In other embodiments, the sleeve540 may be pre-formed prior to insertion between the adjacent vertebrae,as desired by the user, to protect from damage to surrounding anatomicalfeatures of the patient.

Referring now to FIGS. 31-32, the distraction capabilities of surgicaldevice 500 are shown. Referring to FIG. 31A, the surgical device 500further comprises an adjustment mechanism 512, which may be selectivelyengaged by adjustment shaft 510, as shown in FIG. 31A. According to thisembodiment, rotation of adjustment shaft 510 causes rotation ofadjustment mechanism 512, which in turn causes lateral movement ofdistraction plates 514, 516, as best shown in FIGS. 31C-31D.

Referring in detail to FIG. 31C, a rear elevation view of surgicaldevice 500 is shown. In FIG. 31C, distraction plates 514, 516 are shownin a first position. Distraction plates 514, 516 are mechanically linkedto adjustment mechanism 512 by one or more hinged members 517. Referringto FIG. 31D, surgical device 500 is shown in a back elevation view in asecond position of use. According to this position, distraction plates514, 516 have been adjusted laterally in relation to the position shownin FIG. 31C. This adjustment is achieved by rotating adjustment shaft510 once engaged with adjustment mechanism 512, which in turn causes oneor more hinged members 517 to distract distraction plates 514, 516 asshown in FIG. 31D. Accordingly, surgical device 500 is permitted to beadjusted laterally relative to the underlying surgical field, forexample, an intervertebral space.

Although the embodiments described herein are shown within adjustmentshaft that may be rotated by manual force, embodiments of the presentdisclosure are contemplated for use with various powered apparatus whichare known to those of ordinary skill in the art. Such power sourceswould include, but are not limited to, pneumatic and/or electric powersources.

Referring to FIGS. 32A-32B, a side elevation view of the leave behindaccess port 530 and sleeve 540 are shown in corresponding first andsecond positions of use, as described above in connection with FIG. 31Aand FIG. 31B, respectively. According to a preferred embodiment, accessport 530 and sleeve 540 may be positioned prior to or followingdistraction of surgical device 500, and thereby permit access to thedisc space between adjacent vertebrae, as shown in FIGS. 29A-29B.

The access port 530 and/or sleeve 540 may be rigid, semi-rigid, ordeformable to a desired shape and contour. The materials may vary foreach and include but are not limited to metals, metal alloys andpolymeric materials. The access port 530 and/or sleeve 540 allow forvertical compression and adjustment relative to the underlying surgicalfield, and facilitate retraction of and avoidance of contact with softand sensitive tissue surrounding the surgical field. In combination withthe surgical device 500, these components are well suited for placingmaterials in an intervertebral disc space and/or at a patient's laminararch. The access port 530 and sleeve 540 are adjustable to accommodate avariety of different surgical procedures and/or implant materials.

Referring now to FIGS. 33A-33B, the adjustment mechanism 512 andadjustment plates 514, 516 are shown in detailed views. Referring toFIG. 33B, the adjustment mechanism 512 may further comprise a lock bar513, which engages adjustment mechanism 512 and maintains adjustmentmechanism in the desired level of distraction. According to at least oneembodiment, the adjustment mechanism may further comprise one or moresecuring members 515, which may be tightened and secured relative toadjustment mechanism 512 after distraction plates 514, 516 are in theirdesired position. Referring to FIG. 34, various components of surgicaldevice 500 are shown in a disassembled state for further illustration ofthese components.

Referring now to FIGS. 35-38, an alternate embodiment of the surgicaldevice described above in connection with FIGS. 29-34 is shown.According to this embodiment, surgical device 500′ incorporates certainaspects described in relation to FIGS. 29-34 and also certain aspects ofthe embodiments described above in relation to FIGS. 22-28.

Referring to FIG. 35A, a side perspective view of surgical device 500′is shown. Surgical device 500′ preferably includes an adjustmentmechanism 512′, which may be manipulated to cause adjustment of surgicaldevice 500′ by rotation of adjustment shaft 510′, as described ingreater detail below. Referring to FIG. 35B, a front elevation view ofsurgical device 500′ is shown in a first position, and preferablylocated between two adjacent pedicle screws 511′.

Referring to FIGS. 36A-36C, the connection between adjustment shaft 510′and adjustment port 565 is shown in detail. Referring specifically toFIG. 36C, adjustment port 565 preferably comprises a hexagonal-shapedaperture, which may receive a hexagonal-shaped stem 560 located ondistal end of adjustment shaft 510′. Other shapes of stem 560 andcorresponding shapes of aperture of adjustment port 565 are contemplatedfor use with the present disclosure.

Referring now to FIGS. 37A-37C, the operation of adjustment mechanism512′ is depicted. According to the view shown in FIG. 37A, adjustmentmechanism 512′ may comprise two adjustment arms 562, 564, which may movelaterally in relation to slot 561 of adjustment mechanism 512′. Inaddition, adjustment port 565 described above in relation to FIG. 36Amay also move laterally relative to the underlying surgical field.Referring to FIG. 37B, the surgical device 500′ and adjustment mechanism512′ are shown in a second position. Referring to FIG. 37C, adjustmentmechanism 512′ and arms 562, 564 are shown in a third position, wherebybarrel 520′ has been rotated to allow alignment of adjustment shaft 510′and adjustment port 565.

Referring to FIG. 37D, adjustment mechanism 512′ is shown with thebarrel 520′ removed. As shown, the adjustment mechanism 512′ comprises aconnector 555, to which the barrel 520′ may be quickly attached ordetached by rotation of barrel 520′ relative to connector 555. Variousconnection mechanisms are contemplated for use with the embodimentsdescribed above, including but not limited to a slide lock mechanism, aspring-loaded or biased detent, a movable lever, a snap-connection, athreaded connection, a friction or interference fit, a cam-lockingsurface, or a spring-loaded locking mechanism.

Referring to FIGS. 37E and 37F, the adjustment mechanism 512′ is shownin a first and second position of use, respectively. According to theview shown in FIG. 37E, adjustment mechanism 512′ may comprise a gear559 which may be aligned substantially with adjustment port 565. Gear559 is also preferably engaged by one or more teeth to second gear 557.Second gear 557 is preferably connected to another gear 559, whichaccording to the embodiment shown in FIGS. 37E and 37F is substantiallythe same size and shape as gear 559. Gears 559 are preferably engaged byone or more teeth to threaded bars 558 which are mechanically linked orformed as one-piece with one of the respective arms 562, 564. Inoperation, rotation of adjustment shaft 510′ (once engaged throughadjustment port 565) causes rotation of gear 559, which in turn causesrotation of second gear 557 and gear 559, and lateral movement of bars558.

Referring now to FIG. 37F, adjustment mechanism 512′ is shown in asecond position of use, whereby arms 562, 564 are moved laterally inrelation to the body of adjustment mechanism 512′. Accordingly,adjustment of arms 562, 564, once engaged to pedicle screws 511′ mayachieve distraction of the adjacent vertebrae as described above indetail in connection with FIGS. 22-28. Referring now to FIG. 38components described above in relation to surgical device 500′ are shownin an unassembled state to provide further illustration, including abase piece 566.

Although a specific form of adjustment and actuation is described above,it is expressly understood that other mechanisms may be incorporatedwithout departing from the spirit of the present disclosure. Forexample, the distraction mechanism may be comprised or a worm gear, arack and pinion assembly, a ratcheting assembly, a lever, ahydraulically-actuated assembly or by a electronically powered assembly.

FIGS. 39-45 illustrate an access port or IDD 600 of still anotherembodiment of the present invention. As with previously describedsurgical devices, IDD 600 is operable to create distraction before andduring implanting an intervertebral implant and bone graft material. IDD600 may be used in a minimally invasive surgical procedure to createdistraction to expand an operative working space created through arelatively smaller working port or cannula. The IDD 600 may be used inconjunction with another implant system, such as any of the devicesdescribed above, to orient or manipulate an intervertebral implant,including the implants describe hereinafter in conjunction with FIGS.46-75.

Referring now to FIG. 39, IDD 600 is illustrated in a disassembledstate. In one embodiment of the present invention, the IDD 600 isadapted to access a space between adjacent vertebrae. The IDD may alsobe used to distract adjacent vertebrae.

The IDD 600 generally comprises a cannula 604, a distractor 608, and anexpansion tube 612. As will be described in more detail below, thedistractor 608 and expansion tube 612 are sized to be sequentiallypositioned within a bore of the cannula 604. Further, the distractor 608and expansion tube 612 can be slidingly arranged within the cannula 604.As the interior component 608, 612 of IDD 600 are sequentially insertedinto the cannula 604, the amount of distraction increases compared tothe largest external dimensions of the cannula 604. Although illustratedin FIG. 39 with a generally rectangular cross-section, it will beappreciated by one of skill in the art that IDD 600 and its componentsmay have other cross-sectional profiles, such as, but not limited togenerally round or elliptical. Further, although only one distractor 608is illustrated, two or more distractors 608 may be used with the IDD toachieve a desired amount of distraction of adjacent vertebrae.

Referring now to FIG. 40, the cannula 604 generally comprises a body 614with a handle 616 at a proximal end 618. The body includes an expandingtip 620 at a distal end 622.

The body 614 of the cannula may have a rectangular or roundcross-section. However, other shapes of the body are contemplated,including a generally elliptical cross-section. In one embodiment, thebody 614 includes at least one rounded longitudinal corners 615. Therounded corners 615 facilitate rotation of the IDD 600 between andagainst adjacent vertebrae. The radius of each corner 615 may bedifferent.

The body 614 includes a generally hollow interior formed by a bore 617.The shape of the bore 617 may be substantially the same as the exteriorshape of the body. However, in one embodiment, the cross-sectional shapeof the hollow interior is different than the exterior shape of the body.

The body can have any predetermined length and width 648. In oneembodiment, the width 648 of the body 614 is determined based on thesize of an implant intended to be implanted by the IDD 600. In anotherembodiment, the length and width of the body are determined from theportion of the patient's anatomy involved in the surgical procedure.

The expanding tip 620 has a size and shape adapted to be inserted, orwedged, into a small or collapsed intervertebral disk space. The tip 620generally includes two distraction plates 624 interconnected to thedistal end 622 of the body. The plates 624 may be hingedlyinterconnected to the body. Accordingly, the plates can pivot from theclosed state illustrated in FIG. 40, to an open state, illustrated inFIG. 43B, in response to contact by the distractor 608. In oneembodiment, when the plates 624 are in the closed state illustrated inFIG. 40, the tip 620 is substantially pointed.

The plates 624 may have contacting surfaces that are adapted tosubstantially conform to a selected portion of a specific patient'sanatomy. However, other shapes are contemplated. It will be appreciatedthat the plates may also have generic shapes adapted for use with anypatient. In addition, the plates 624 may include indicia or graduationsto indicate a depth of insertion between adjacent vertebrae of thepatient.

The handle 616 is secured to the body 614 of the cannula and has a shapeselected to facilitate grasping and rotation of the IDD 600 during asurgical procedure. A manual or mechanical impact force may be appliedto the handle to push the tip 620 of the cannula between the adjacentvertebrae. Accordingly, in one embodiment of the present invention thehandle 616 and other portions of the cannula are sufficiently rigid toreceive an impact force from a hammer or other impact device.

The handle 616 may have a shape or indicia to help orient the IDD 600and the tip 620 with respect to the patient's anatomy to ensure the IDD600 is in a predetermined orientation and position. In one embodiment,the indicia comprise letters or symbols that indicate a portion of thepatient's anatomy targeted by the IDD 600. In another embodiment, theshape of the handle or the indicia indicate a reference orientation foralignment with respect to a portion of the patient's anatomy.

Referring now to FIG. 41, the dynamic distractor 608 generally comprisesdistracting blocks 628 interconnected to a handle 632 by armatures 630.The distractor 608 may comprise one integral piece. Alternatively, thedistractor 608A may comprise one piece. The single distractor 608A maybe used individually with IDD 600. Alternatively, if a different amountof distraction of adjacent vertebrae is required, distractor 608A isadapted to be combined with a similar piece (not illustrated) during asurgical procedure.

The distracting blocks 628 are located on the distal end 622 of thearmatures 630. In one embodiment, the distracting blocks 628 have anexterior shape that substantially matches the shape of the bore 617 ofthe cannula 604. The blocks 628 may include radiused corners 615 tofacilitate rotation of the blocks between and against the adjacentvertebrae. One or more of the corners 615 may have a different radiuscompared to the other corners. Optionally, the radiused corners 615 mayserve as keys to mate with internal features of the cannula bore 617. Inthis manner, the distractor 608 can only be inserted into the cannulawhen in a predetermined orientation.

Although the blocks 628 are illustrated with a generally rectangularcross-section, it will be appreciated by one of skill in the art thatthe blocks 628 may have any shape determined to facilitate distractionof adjacent vertebrae. Accordingly, the shape of the blocks 628 maydetermine the shape of the cannula bore 617. Further, distraction block628A may have a different size and shape compared to distraction block628B. In one embodiment, the shape of each distraction block 628A, 628Bincludes different patient contacting surfaces adapted to align withdifferent portions of the patient's anatomy. Providing patient-matchedsurfaces on the blocks 628 may help orient the IDD 600 and ensure thatthe IDD 600 is being docked off appropriate anatomy of the patient. In adifferent embodiment, the shape of at least one of the distractionblocks 628 is selected to align the distractor 608 in a predeterminedorientation with the cannula 604 to facilitate proper use of the IDD600. The distractor blocks 608 may also have a dimension selected toachieve a predetermined amount of distraction of adjacent vertebrae.However, it is contemplated that the blocks 628 may have a generic shapeadapted to align the IDD 600 with a specific anatomical feature of anypatient.

Any number of distractor blocks can be used with the distractor of thepresent invention although only two distractor blocks are illustrated.For example, in one embodiment, the distractor may include fourdistractor blocks with two blocks positioned distally in front of twoblocks that are positioned more toward the proximal end 618. Each of thefour blocks may have a decreased size compared to the size of the twodistractor blocks 628A, 628B. Accordingly, the four distractor blocksmay be advanced sequentially in pairs to incrementally distract theadjacent vertebrae.

When the distractor 608 is inserted into the cannula 604, the distal end629 of the blocks 628 presses against an interior surface of thedistractor plates 624. As the distractor is pressed distally, the blocks628 move the distractor plates 624 to an open position (illustrated inFIG. 43B). Accordingly, the blocks 628 serve to expand the expanding tip620 of the cannula within the disk space to further distract theadjacent vertebrae. The blocks 628 also facilitate further distractionof the adjacent vertebrae. After the blocks are fully advanced to thedistal end 622 of the cannula, the blocks protrude at least partiallyfrom the cannula bore 617, also illustrated in FIG. 43B. With the blocks628 in this position, when the IDD 600 is rotated, the blocks 628further distract the adjacent vertebrae to create and maintain workingspace within the disk space.

The distractor handle 632 may have the same general size and shape ofthe cannula handle 616. In one embodiment, the distractor handlecomprises two portions 632A, 632B associated with each of the armatures630A, 630B. The handle portions 632A, 632B can be separated radially toenable the expansion tube 612 to fit within the cannula bore 617 betweenthe armatures 630. The handle 632 may also be sufficiently durable toreceive an impact force from an impact device such as a hammer.

The distractor handle 632 may include indicia similar to the indicia ofthe cannula handle. For example, indicia of the distractor handle 632may indicate a direction of intended rotation to ensure planneddistraction of adjacent vertebrae. The indicia may also indicate anintended orientation of the distractor 608 for proper insertion withinthe cannula 604. Optionally, in one embodiment, the distractor handle632 is adapted to interconnect to the cannula handle 616 to preventunintended or inadvertent movement of the distractor 608 within thecannula bore 617. In another embodiment, the distractor handle 632 mayinclude a latch or lever operable to advance the blocks 628 within thecannula bore 617 to force open the distraction plates 624 of thecannula. Optionally, the cannula 604 may include a ratchet to move thedistractor 608 to the distal end. Further, in one embodiment, the IDD600 is adapted for use with device 200. Accordingly, the IDD 600 may beinserted through barrel 220 and each of the cannula 604, distractor 608and expansion tube 612 advanced using the trigger 282 of device 200.

Referring now to FIG. 42, the expansion tube 612 of one embodiment ofthe present invention generally comprises a shaft 636 and a handle 640.The handle 640 may be the same as, or similar to, handles 616, 632 ofthe cannula and the distractor.

The shaft has an exterior shape substantially conforming to the cannulabore 617 after insertion of the distractor 608 into the cannula. Anexterior surface of the shaft 636 may be keyed to align with thedistractor armatures 630. In one embodiment, the key is a recess 638formed on at least one surface of the shaft.

The shaft includes a hollow bore 642. The bore 642 has a size and shapeadapted to receive an intervertebral implant. In one embodiment, thebore 642 includes a protrusion 644 to mate with the implant and/orspecific instruments, such as any of the rods 30 described above, usedto prepare the disk space and or deliver implants or bone grafts. Inanother embodiment, two protrusions 644 may form a slot 643 (best seenin FIG. 45) with a decreased width 645 along at least one of theinterior sides of the bore 642. The slot 643 may have a width 645 sizedto guide a portion of an implant, such as a module describedhereinafter, through the tube bore 642.

Referring now to FIG. 43, in operation, the tip 620 of the cannula 604is inserted at least partially between adjacent vertebrae to partiallydistract the vertebrae a first distance. The distractor 608 is insertedinto the cannula bore 617 at the proximal end 618 of the cannula body614. FIG. 43A illustrates the distractor partially inserted in thecannula. As the distractor is advanced further into the cannula, thedistal end 629 of the distraction blocks 628 press against interiorsurfaces of the distraction plates 624. The plates 624 pivot orotherwise move to the open position, as illustrated in FIG. 43Baccording to one embodiment of the present invention. The movement ofthe plates 624 expands the distal end 622 of the IDD 600 in at least onedimension and further distracts the adjacent vertebrae a seconddistance.

Referring now to FIG. 44A, the distal end 622 of the cannula 604 has apredetermined width 648. The expansion tube 612 can be inserted into thecannula bore 617 after the distractor 608 to increase the width of theIDD. As the expansion tube 612 is pressed into the cannula bore, the key638 of the tube 612 moves along the distractor armatures (notillustrated in FIG. 44), forcing the armatures apart. The separation ofthe armatures applies a force to each distractor block 628A, B. Theforce of the tube 612 against the armatures forces the distractor blocks628A, B to move radially outward, as illustrated in FIG. 44B, whichillustrates the expansion tube 612 substantially completely insertedinto the IDD 600. The outward movement of the blocks 628A increases thewidth 650 of the distal portion 622 of the IDD 600. The width 650 isgreater than the width 648 of the cannula body 614. Accordingly, theadjacent vertebrae may be distracted by an amount greater than thedistraction provided by the cannula body 614.

Optionally, after distractor 608 is inserted into the cannula bore 617and the blocks bilaterally extended as illustrated in FIG. 44B, a seconddistractor 608 with at least one distractor block may be inserted intothe cannula bore 617 to achieve a second, greater amount of distraction.Any number of distractors may be inserted through the cannula bore tosequentially increase the distraction between adjacent vertebrae.

It will be appreciated that in one embodiment of the present invention,a distractor 608A with a single block 628A may be inserted through thecannula bore to provide a different amount of distraction. In thisembodiment, when the expansion tube is pressed into the cannula bore,the single block 628A would extend out radially similar to the bilateralextension of blocks 628A, 628B illustrated in FIG. 44B.

Optionally, the IDD 600 includes a lock mechanism to fix the distractorblocks 628A, 628B in the radially extended position. After the lockmechanism is engaged, the tube 612 may be removed from the bore of thecannula 604 and the distractor blocks 628A, 628B will be retained in theextended position. In this manner, bore of the cannula can be used toinsert an implant between the vertebrae. This may be beneficial for someprocedures as the bore of the cannula 604 has a greater internal widththan the bore 642 of the tube 612.

Referring to FIG. 45, the IDD 600 can be rotated axially to furtherdistract the adjacent vertebrae a third distance. The IDD 600 can berotated prior to, or after, the distraction blocks 628 have beenexpanded radially by insertion of the expansion tube 612. The handle 616may be shaped to provide a reference to the orientation of thedistraction blocks 624. For example, the handle may include narrowportions 646 that generally point in the same direction as thedistraction blocks 624. Rotating the IDD 600 up to approximately 90degrees allows the user to create distraction equal to width 650 withinthe disk space that is larger than the width 648 of the cannula itself.Optionally, the distractor 608 can be rotated axially within the bore ofcannula 604 without rotating the cannula. In another embodiment, theexpansion tube 612 can be rotated axially without rotating either thecannula or the distractor.

As shown in FIG. 45, after the distraction blocks 624 have been extendedradially, the bore 642 of the expansion tube 612 has an opening facingthe distal end 622 of the IDD. The tube bore 642 may accordingly be usedto guide an implant into the space between the adjacent vertebraedistract by the IDD. Although not illustrated in FIG. 45, it will beappreciated that tools, such as rod 30 may be guided through the tubebore 642 to place and adjust the orientation of an implant in theintervertebral space. Other tools known to those of skill in the art mayalso be used with the IDD to position the implant.

FIGS. 46-49 show a surgical device 700 according to one embodiment ofthe present disclosure. The surgical device is suited for insertion inan intervertebral space after the space has been accessed and preparedusing the above instruments. It will be appreciated that theintervertebral space can be accessed and prepared for insertion ofdevice 700 using other known tools and techniques. Surgical device 700provides bi-lateral support in the disc space. According to a preferredembodiment, the surgical device is comprised of a primary module 701,one or more adjustable modules 702, 703, 704, 705, 706, and one or moreadjustable armatures 707, 708, 709. In one embodiment, the modules aresubstantially rigid. In another embodiment, the modules may besubstantially solid with no interior voids. Accordingly, the modules areadapted to resist deformation or damage caused by forces received fromthe adjacent vertebrae. The device 700 may be assembled during asurgical procedure. Accordingly, a user may select armatures of desiredsize and shape, interconnect the selected armatures to selected module,and then select one or more modules to be interconnected to thearmatures. The assembled device may be assembled before insertion in theintervertebral space. Optionally, individual armatures and modules maybe placed within the intervertebral space and subsequently assembled.Accordingly, a variety of modules and armatures may be provided prior tothe surgical procedure. Desired modules and armatures may then beselected and assembled during the surgical procedure. In this manner,the size and shape of the device may be adjusted during the procedure toaccount for conditions encountered during the surgical procedure.Further, a surgeon may select an armature adapted for use with only onemodule (for example, armatures 1609, 1609A described in conjunction withFIGS. 71-72). Alternatively, the surgeon may select an armature with twomodules, such as armatures 1309, 1409 described with FIGS. 67-68 below.In addition, after the device is inserted into the intervertebral space,the device may be removed and at least partially disassembled. Differentarmatures or modules may then be selected for interconnection to thedevice. The device may then be reassembled and re-inserted into theintervertebral space.

The modules 701-706 may have a variety of shapes and sizes. The modulesmay optionally include exterior surfaces that are generally smooth andwithout protrusions to facilitate passage of the device 700 through thedisc space during implantation. Exterior surfaces 732 of the modulesfacing the distal end 726 of the device are generally rounded with aconvex or arcuate distal surface. Surfaces 730 of the modules facingradially inward may include perforations or webbing to receive bonegrowth material to promote fusion of adjacent vertebrae. Optionally,surfaces of the device may include apertures 734, illustrated in FIG.48, for delivery of bone growth material around the device afterinsertion in the intervertebral space.

In one embodiment, the modules have shapes selected to nest togetherwhen the surgical device is in the insertion configuration, asillustrated in FIG. 46. In one embodiment, the primary module isgenerally “H” shaped. However, other shapes are contemplated. Theproximal modules 703, 705 are generally “D” shaped. In one embodiment,the distal module 702 is shaped generally like a snow cone. In anotherembodiment, modules 704, 706 are generally “D” shaped with an arcuateradially outer edge and a radially inner edge adapted to generallyconform to the exterior surface of the distal module 702. In stillanother embodiment, when the device 700 is in the insertionconfiguration, the device is substantially symmetrical along an axissubstantially concentric with the adjustable armature 707.

The shape of each module may be selected to facilitate assessment of thealignment of the device by use of medical imaging devices. For example,one or more of the modules may have a non-uniform shape to identify theorientation of the device 700 within the disc space. In addition,radiographic markers may be positioned at a variety of locations on themodules to facilitate assessment of the location and orientation of theimplant in the disc space. The markers may be of any type viewable bymedical imaging devices, such as an X-ray apparatus.

The modules may also include shapes and surfaces used to distractadjacent vertebrae. For example, the modules may include a tapered shapethat can be used to distract the vertebrae for receiving the surgicaldevice. In one embodiment, the modules 701-706 have a substantiallyuniform thickness 715, as illustrated in FIG. 48. In another embodiment,module 702 includes a surface at the distal end 726 with a reducedthickness 715. In still another embodiment, modules 702, 704, 706 mayeach have a uniformly tapered thickness 715 similar to a wedge. In stillanother embodiment, the device has a first thickness 715 at the distalend 726 and a second, greater thickness 715A at the proximal end 728. Inthis embodiment, the distal modules 702, 704, 706 may thinner than theproximal modules 703, 705.

Optionally, the exterior surfaces 732 of the modules may be adapted toengage surfaces of the adjacent vertebrae. For example, in oneembodiment, the modules include groves, ridges, spikes, or otherprotrusions to resist unintended movement or migration of the devicewithin the vertebral space. Any of the modules can have exteriorsurfaces that are patient specific. The patient specific surfacesinclude contours selected to substantially conform to a predeterminedportion of the patient's anatomy. Accordingly, the modules can includeexterior surfaces with shapes adapted to fit to a specific locationwithin the intervertebral space.

The armatures are moveable with respect to the primary module 701. Inone embodiment, the primary module 701 comprises apertures or slots forreceiving adjustable armatures 707-709, and according to this embodimentone or more adjustable armatures 707-709 may be moved through slots toachieve a variety of desired configurations. Positioning of the modulesmay be achieved in a variety of configurations by movement of the one ormore adjustable armatures. For example, in this embodiment two modules703, 704 are connected by one adjustable armature 708 and two differentmodules 705, 706 are connected by a different adjustable armature 709.One additional module 702 is connected to yet another armature 707.Positioning of armatures 707-709 relative to the primary module 701determines the position of the respective modules 702-706 associatedwith the adjustable armatures 707-709.

In one embodiment, the armatures 707-709 may be adjustable bytranslation relative to one or more modules, such as the primary module701 shown in FIG. 46. For further illustration, compare FIGS. 46-47 andFIGS. 47-49. Certain armatures 708, 709 may further be adjustable bymeans of a pivot or hinged connection 710, 711, such as may be seen whencomparing FIG. 46 with FIG. 47. The hinges 710, 711 may be of any type.

In FIG. 46, the surgical device 700 comprises three adjustable armatures707-709 and six modules 701-706 in a initial or insertion configuration.In the insertion configuration, the surgical device has a relativelycompact shape adapted to be positioned between vertebrae. The insertionconfiguration also enables the surgical device 700 to be inserted into avertebral space through a cannula of an insertion tool or IDD asdescribed above. Said another way, in the insertion configuration, thesurgical device has a comparatively narrow width 714. In one embodimentof the present invention, when the surgical device is in the insertionconfiguration, none of the modules project beyond the width 714 of theprimary module 701.

Other types of adjustment are contemplated and described in alternateembodiments below. Armatures may be advanced or retracted bymanipulation of a tool used to insert the surgical device 700 into thevertebral space. The adjustability of the armatures can be controlled toselectively expand or contract of the surgical device 700 to a specificposition or size. In one embodiment, an adjustment mechanism may bemanipulated to advance or retract one or more of the armatures 707-709.The armatures can be adjusted independently or as a group. In oneembodiment, the adjustment mechanism is an internal screw, such as a setscrew, operable to manipulate the armatures. The internal screw may haveany thread type with any desired pitch. In one embodiment, the threadsof the screw are calibrated such that each rotation of the screwadvances or retracts the armatures a predetermined amount. In anotherembodiment, the threads of the screw engage threads formed on a portionof the armatures. As the screw is rotated, the threads of the armaturesadvance or withdraw the armatures from the primary module 701. Inanother embodiment, the position of one or more of the armatures isadjusted by a rack and pinion type connection between the primary moduleand the armatures. The connection is made by a plurality of slots on thearmatures and gears or teeth of the primary module. As the adjustmentmechanism is manipulated, the teeth of the primary module engage theslots of the armatures to change the position of the armatures withrespect to the primary module. In one embodiment, the rack and pinionconnection is operable to move each module axially and/or radially. Inone embodiment, the adjustment mechanism is associated with theengagement portion 720 described below. In another embodiment, theengagement portion 720 can be actuated by a rod of an IDD 10, 110 toadvance one or more distal modules 702, 704, 706 to distract theadjacent vertebrae.

In one embodiment, different internal screws are associated with eacharmature 707-709, each screw adapted to independently advance or retracta respective armature. In another embodiment, illustrated in FIGS.51-52, the internal screw is operable to lock the armatures 707-709 inany selected position to prevent unintended or inadvertent movement ofthe armatures and their associated modules.

In one embodiment, stops may be provided on armatures 707-709 to limitthe amount of movement of the armatures with respect to the primarymodule 701. Additionally or alternatively, the armatures may includemeans to indicate a relative movement of the armatures through the slotsof the primary module 701 as the armatures are advanced or withdrawn. Inone embodiment, the means to indicate comprises indicia provided onportions of the armatures 707-709. In one embodiment, the indiciacomprise a series of marks forming a graduated scale. In anotherembodiment, the means to indicate comprises detents. As the armaturesare adjusted, the detents may provide feedback to the operator, such asan audible click or tactile vibration. In still another embodiment, themeans to indicate are discernible by a medical imaging device. Inanother embodiment, the means to indicate are embedded within or appliedto the surface of the surgical device 700 and the means to indicate aremade of a material that is discernible by the medical imaging device. Instill another embodiment, the means to indicate include radiolucentmaterials.

FIG. 47 is another top plan view of the surgical device of FIG. 46. Inthis embodiment, the surgical device has been adjusted to a secondorientation by pivoting a portion of the adjustable armatures 708, 709from the first orientation shown in FIG. 46. Armatures 708, 709 eachcomprise a first portion interconnected to a second portion. In anotherembodiment, the first portion of the armature is rotationallyinterconnected to the second portion. Thus, the first portion can betranslated in one or two planes with respect to the second portion. Inanother embodiment, the first portion is interconnected to the secondportion by hinges 710, 711. In this manner, the surgeon or other medicalprofessional may quickly and easily manipulate the surgical device andexpand the location of one or more modules of the surgical device, andin turn achieve a greater net surface area for the surgical device (asshown, for example, in FIGS. 48-49). Additionally, the surgeon canchange the orientation of the armatures and the modules to contact, oravoid, portions of the patient's anatomy or to improve visibility duringa surgical procedure.

FIG. 48 is a perspective view of the surgical device in the orientationshown in FIG. 47, illustrating the thickness 715 of the device. When inthis orientation, modules 702, 704, 706 preferably comprise little to nogaps therebetween and otherwise form a nearly congruent surface of theleading or distal edge 726 of the surgical device. The outer surfaces ofmodules 702, 704, 706 are preferably smooth and/or rounded to assistwith insertion and/or distraction of adjacent boney anatomy and to avoidunnecessary trauma to surrounding anatomy.

During insertion of the surgical device 700, the device width 714dimension is aligned generally perpendicular to the general plane of thenatural disc and the intervertebral space (which is generally horizontalin an erect human, transverse to the longitudinal extent of the spine).Thus, in the configuration illustrated in FIGS. 47-48, the modules mayfit at least partially between adjacent vertebrae to distract thevertebrae. In one embodiment, the shape of module 702 is selected to bereceived between the adjacent vertebrae to provide an initialdistraction amount. In another embodiment, one or more of the modules702, 704, 706 may have a thickness 715 that decreases from a largerdimension proximate to the primary module to a smaller dimension distalto the primary module 701, similar to the device illustrated in FIG.65C. Thus, the modules 702, 704, 706 may form a wedge that can beutilized to fit between the adjacent vertebrae to provide an initialdistraction amount.

FIG. 49 is another top plan view of the surgical device of FIG. 46. Inthis embodiment the surgical device is in a final or deployedconfiguration. The adjustable armatures 708, 709 have been moved throughrespective slots in the primary module 701, which in turn has causedmodules 704, 706 to move and expand from the leading end of the surgicaldevice and modules 703, 705 to move and contract toward the primarymodule 701. In addition, adjustable armature 707 has also been movedrelative to primary module 701 so that module 702 is expanded outwardlyfrom the leading edge of the surgical device.

Once the surgical device has been inserted into the intervertebralspace, the device may be rotated so that the device width 714 dimensionis aligned generally parallel to the general plane of the natural discand the intervertebral space. The adjustable armatures 707-709 may thenbe adjusted based on surgeon preference or patient anatomy until thedesired configuration is achieved. In one embodiment, the final ordeployed configuration will be secured by a tool, which may be used toaffix the adjustable armatures in the desired location relative to theprimary module 701. In another embodiment, the surgical device isoperable to retain the adjustable armatures in the deployedconfiguration. For example, in one embodiment, surgical device includesa lock means. The lock means may comprise any structure suitable toprevent unintended or inadvertent movement of the adjustable armatures.In one embodiment, the lock means comprises detents that are biased toextend into voids to prevent the adjustable armatures from moving fromthe deployed configuration. In another embodiment, the lock meanscomprises a fixture 724 that applies a force to the armatures asillustrated in FIGS. 51-52.

Modules are preferably made of one of the materials described above.Adjustable armatures may also be comprised of the materials describedabove, however, in a preferred embodiment the armatures are comprised ofa material known as Nitinol or an alternative material having similarproperties as Nitinol. As will be appreciated by one of skill in theart, adjustable armatures made of Nitinol may be at least partiallyflexible, allowing the surgeon to reshape the surgical device during thesurgical procedure without damaging the adjustable armatures. Adjustablearmatures made of Nitinol have shape memory and can be formed into andhold a shape better than armatures made of other materials. In theseembodiments, the critical temperature of the Nitinol used to form thearmatures may be selected to be less than a temperature in an operativeenvironment for the surgical device. A desired shape for each adjustablearmature is memorized for temperatures above the critical temperature sothat the desired shape of each adjustable armature is restored duringuse when the surgical device 700 is implanted. In certain embodiments,the critical temperature is selected to be less than a body temperatureof the patient.

For example, by selecting a transition temperature of the Nitinol of theadjustable armatures to be below room temperature, the adjustablearmatures can have superelastic properties. Thus, it will be understoodby those of skill in the art that one or more of the adjustablearmatures of the surgical device may be bent or the shape of thearmature adjusted during the surgical procedure for an indefinite periodof time without permanent deformation. In use, after the surgical deviceis implanted into the patient's body, the temperature of the adjustablearmatures will increase above the critical temperature returning theadjustable armatures to their original shapes.

Adjustable armatures are preferably smaller in dimension than modules,and in a final placement or deployed configuration permit a surgeon orother medical professional to place bone graft and/or other bone growthmaterial around the armatures for facilitating fusion between theadjacent vertebral bodies. In the embodiments described herein, agreater amount of bone graft or bone growth material may be placedaround the surgical device when it is in the deployed configuration thanwith other prior art surgical devices.

Cannulae or cutaway features may be present in one or all of the modulesthrough which surgeons place graft material throughout the construct.For example, in one embodiment, the modules 702-706 include channels orbores operable to conduct graft material from a surgical tool, such as asyringe, to exterior surfaces of the modules. In one embodiment, themodules may include a plurality of bores to receive graft material.Thus, the modules of one embodiment may comprise a rigid spongestructure to promote, or benefit from, bone in-growth in theintervertebral space. In still another embodiment, the adjustablearmatures 707-709 include hollow bores that communicate with apertures734 in the modules 702-706. In this embodiment, the surgeon may injectgraft material into an aperture 720 in one of the modules, such as theprimary module 701, which then flows through the armatures and out ofthe apertures 734 of modules 702-706.

FIGS. 50-52 are views of a surgical device 700 according to theembodiment described above in connection with FIGS. 46-49. Here, anengaging portion 720 is illustrated on a proximal portion 728 of theprimary module 701. The engaging portion 720 is adapted to interconnectthe device 700 to an insertion tool or a fixture device. In oneembodiment, the engaging portion 720 comprises an aperture with internalthreads for engaging a threaded tool or fixture device. In anotherembodiment, the aperture includes detents or latches to releasablyengage the tool or fixture device. In still another embodiment, theengaging portion 720 comprises a loop or hook for grasping by aninsertion tool or rod described above. It will be appreciated that theengaging portion 720 may be positioned at different locations, or morethan one location, on the device.

Referring now to FIG. 51, an instrument or tool 722 is shown forinserting a fixture device, such as a screw 724, or other connectionmember to the primary module 701. The screw 724 is inserted into theaperture 720 in the primary module. After the screw is inserted into theaperture 720 in the primary module 701, the screw engages surfaces ofthe adjustable armatures 708, 709, as best seen in FIG. 52. In oneembodiment, the screw 724 at least slightly deflects or bends thearmatures, preventing movement of the armatures through the primarymodule. The screw 724 thereby secures the adjustable armatures in anyconfiguration selected by a user, including the deployed configurationor the insertion configuration. In one embodiment, the screw may berotated into the aperture 720 to permanently deform the armatures 708,709 to prevent movement of the armatures. Thereafter, the screw 724 maybe removed from the aperture.

In one embodiment of the present invention, the surgical device isdeployed with a connection member 724 pre-positioned in the aperture 720in a disengaged position. After the surgical device 700 is positioned inthe intervertebral space and the adjustable armatures moved to theirdeployed configuration, the connection member is moved to an engagedposition. Moving the connection member to the engaged position maycomprise rotating the connection member to cause a distal portion of theconnection member to apply a force to the adjustable armatures 708, 709.In another embodiment, moving the connection member may comprise pushingthe connection member further into the surgical device 700 to contactthe adjustable armatures. For example, the connection member may bebiased in a disengaged position. Pushing the connection member inwardmoves the connection member to the engaged position to prevent movementof the armatures.

Although illustrated with the surgical device 700, it will beappreciated by one of skill in the art that all embodiments of thesurgical devices of the present invention described herein may includean aperture adapted to receive a fixture device or other connectionmember to secure the adjustable armatures in a predetermined position.Other similar connection members are contemplated for use with thepresent disclosure.

The engaging portion 720 may also be used for loading implant materialor bone growth material into the intervertebral space. The engagingportion may communicate by bores to a variety of apertures 734(illustrated in FIG. 48) in the exterior surface of the surgical device700. A deliver system for the implant material, such as a syringe, maybe interconnected to the engaging portion 720 to deliver the implantmaterial through the device. Optionally, in one embodiment, the engagingportion 720 may be used for loading implant material after a fixture,such as a screw, is inserted into the engaging portion to lock thearmatures in a set position.

FIG. 53 is a perspective view of a surgical device 700 according to theembodiment described in relation to FIGS. 46-52 positioned against avertebral body V. Although oriented as being placed via a direct lateralapproach, it is expressly understood that this particular embodiment maybe used in one of the other approaches described herein. Furthermore,the surgical device 700 may be manipulated by rotation once placedwithin the disc space if desired.

FIGS. 54-55 are top plan views of a surgical device 800 according to analternate embodiment of the present disclosure. In this embodiment,modules 804, 806 have been sized and shaped differently than the modules704, 706 of FIG. 46, yet still achieve the benefits of the presentdisclosure. Further, armatures 808, 809 have non-linear shapes. In oneembodiment, armatures 808, 809 have a generally arcuate shape.Accordingly, several different sizes and shapes of modules (andarmatures) are contemplated for use with the present disclosure, and donot depart from the novel aspects described herein. When the armatures808, 809 are moved through their respective slots in the primary module801, modules 804, 806 move in a non-linear motion away from the leadingend of the surgical device to a deployed configuration, as illustratedin FIG. 56E-F.

According to this embodiment, armatures 807-809 are preferably comprisedof Nitinol or a similar material. The material properties of thearmatures permit the armatures to bend and deflect a significant amount,without compromising their original shape or failing due to shearforces. Here, the surgical devices may be placed in an initial orinsertion configuration by manipulating the armatures as shown in FIG.54. In this configuration, the surgical device has a width 814 that isnarrow enough to be placed through a 10-25 mm tube, for example, such asthe type used in a minimally-invasive surgical procedure, includingsurgical devices described above in conjunction with FIGS. 1-45. In thedeployed configuration, shown in FIG. 55, the surgical device 800 has anincreased width 814A. The description accompanying FIGS. 46-53 withrespect to additional manipulation of armatures and respective modulesapplies equally to this alternate embodiment.

FIGS. 56A-F include multiple views of surgical devices 700, 800according to various embodiments, which are provided to illustrate thevariety of different configurations possible for the surgical device.For instance, only one armature may be adjusted to cause expansion ofthe respective module associated with the armature. As another example,certain armatures may be retracted, as opposed to expanded, to achieveproper balancing or load support for the patient's surgical need.Furthermore, a number of different sized and shaped modules may beprovided depending on the specific application. In addition, individualmodules may be rotated axially with respect to the associated armature.For example, as illustrated in FIGS. 56C, 56F, armatures 703, 803, and806 have been rotated compared to their configurations in FIGS. 56A,56D, respectively. A number of variations are possible without changingthe basic structure of the surgical device.

FIGS. 57-60 show a surgical device 900 according to another alternateembodiment of the present disclosure. In FIG. 57, the surgical device isshown in a top plan view in an insertion configuration suitable forinsertion through a tube, as described in more detail above.Accordingly, at least a portion of the surgical device has a narrowwidth 914. The modules 902-905 are connected by armatures 908, 909 thatare coupled to a primary module 901. The armatures are preferablycoupled to primary module 901 in a manner similar to a scissor joint(not shown in detail), which permits the armatures to retract or expandsubstantially simultaneous to one another.

FIG. 58 is a front perspective view of the surgical device 900 of FIG.57. The surgical device may be placed in the insertion configuration andinserted so that the smooth and/or rounded surfaces of congruent modules903, 905 assist with distraction of adjacent vertebrae. Then thesurgical device may be rotated so that the substantially flat surfacesof module (i.e., the top surfaces of the modules shown in the plan viewin FIG. 57) are facing toward the vertebrae. In this manner, the implant900 provides yet another benefit by eliminating the need for specialtyinstruments or tools to further distract the disc space or other boneyanatomy.

FIG. 59 is another top plan view of the surgical device 900 of FIG. 57,now placed in a deployed configuration. Here, modules 902-905 have beenexpanded away from each other via movement of armatures 908, 909,increasing the width 914A of the device. FIG. 60 is a perspective viewof the surgical device 900 of FIG. 59 in the deployed configuration andillustrating an aperture 934 formed on a surface of module 903. Theaperture may be used to deliver bone growth material as described above.The description accompanying FIGS. 46-56 with respect to the structureand features of surgical devices 700, 800 applies equally to thisalternate embodiment of device 900.

FIGS. 61-64 depict a surgical device 1000 according to yet anotheralternate embodiment of the present disclosure. This surgical device issimilar to the one described in connection with FIGS. 57-60; however,the primary module 1001 is substantially hollow and includes an aperture1016 in its central portion as best seen in FIGS. 62, 64. The portion ofarmatures 1008-1009 within the aperture 1016 of the primary module 1001has been omitted in the perspective views of FIGS. 62-64 for clarity andto show an aperture 1017 through the primary module 1001 associated witharmature 1009. In the insertion configuration of surgical device 1000,illustrated in FIGS. 61-62, a gap or channel 1012 may remain between themodules 1003, 1005 at the distal end of the device.

This substantially hollow body 1001 permits placement of bone graft orother bone growth material and decreases the weight and cost ofmanufacturing the surgical device 1000. This embodiment also facilitateslocation of the primary module 1001 when viewed by radiographic or othersimilar imaging, and in turn makes it easier for a surgeon to verify theproper placement of the surgical device. Other known techniques, such asthe placement of one or more radiographic markers along the surfaces ofmodules 1001-1005 or armatures 1008-1009 may also be incorporated withthe various embodiments described herein to facilitate final placementof the surgical device.

FIG. 65A-E are various views of a surgical device 1100 according to yetanother alternate embodiment of the present disclosure. In thisembodiment, two armatures 1108, 1109 connect two modules 1102-1103 and1104-1105 each. Here, an engaging portion 1120 comprises a generally “C”shaped ring. The engaging portion 1120 is adapted to be grasped orhooked by a rod of an insertion device to orient or re-position thedevice 1100. Other shapes for the engaging portion are contemplated. Inanother embodiment, the engaging portion may be a rod shaped projectionadapted to be grasped by jaws of pliers or tweezers, for example.

Each of the modules 1101-1105 has a unique shape and size. The modulesmay have a shape and size selected based on the anatomy of a particularpatient. The modules may also be tapered or sloped or otherwisecontoured to facilitate insertion and manipulation, as best seen in theside elevation view of FIG. 65C. Thus, the surgical device 1100 may havea first thickness 1115 proximate to module 1104 that decreases to asecond thickness 1115A at a distal end of the device. FIG. 65C alsoillustrates that one armature 1108 may be offset vertically to preventcontact with the other armature 1109.

FIG. 65D illustrates the surgical device 1100 after the armatures havebeen adjusted into a deployed configuration for use proximate to avertebral body V, as shown in FIG. 65E. One or more of the modules mayalso comprise a threaded or other style connector for use in couplingthe implant with a particular insertion tool or instrument (not shown inFIGS. 65A-E). In other embodiments, the surgical device assembly isplaced within a device delivery instrument, as described in greaterdetail above.

FIG. 66A-B are plan views of an alternate embodiment of a surgicaldevice 1200 of the present disclosure. This surgical device is similarto the one described in FIGS. 65A-E, except one of the armatures,armature 1209, is curved or bowed to provide additional adjustabilityand manipulation. The other armature 1208 is substantially linear. Thisembodiment also reduces the width 1214 of the surgical device when inits insertion configuration. Surgical device 1200 also illustrates avariety of shapes of modules 1202-1205. As previously described, eachmodule may have a unique size and shape compared to the other modules.The modules may also be symmetric or asymmetric. The primary module 1201includes an engaging portion 1220 comprising an aperture. The aperturemay have internal threads.

FIGS. 67A-D and 68A-D are various views of surgical devices 1300, 1400according to yet another alternate embodiment of the present disclosure.Here, only one armature 1309, 1409 associated with two modules (1304,1305 and 1404, 1405, respectively) and primary modules 1301, 1401 toprovide surgical devices that may be manipulated in a variety ofconfigurations. Similar to the embodiments described above in connectionwith FIGS. 46-52, these embodiments may further comprise a lockingmechanism to secure the armature in its desired location once thesurgical device is deployed. In certain embodiments, the armatures 1309,1409 comprise indicia that are visible to the surgeon either manually orvia the use of radiographic or other equipment, so the surgeon mayverify the translation of the armature relative to the primary module1301, 1401 in its deployed configuration. The surgical device 1400 mayalso include an aperture 1416 in the primary module 1401 that may beused to deliver bone graft material and to verify the position of thedevice in the vertebral space. Thus, in one embodiment, the aperture1416 has an asymmetric shape adapted to indicate an orientation of theprimary module 1401.

Features of the surgical devices shown in FIGS. 67A-D and 68A-D areideally suited for a transforaminal lumbar interbody fusion (TLIF)approach. The surgical devices 1300, 1400 preferably comprise afull-radius or bullet-shaped nose 1318, 1418 for ease of insertion, andfurther comprise a central cutout or void 1416, which may be loaded withbone graft material prior to insertion. Furthermore, by providing asingle adjustable armature 1309, 1409, the surgical device may movefreely relative to the primary module 1301, 1401, which provides thedesired amount of disc space distraction upon insertion, until thearmature is locked in place.

The components of this embodiment may further be comprised of a shapememory alloy, such as Nitinol, or other material comprising an abilityto bend and yet retaining, or returning to, its original configuration.Alternatively, the components may be pre-formed and comprised oftitanium or equivalent material.

Although the embodiments described above each use the term “primarymodule,” it is expressly understood that the surgical device may beprovided without a primary module. Thus, this term is used merely forillustration and not to unduly limit the present disclosure.

FIGS. 69A-B and 70A-B show perspective and plan views of a surgicaldevices 1500, 1500A according to other alternate embodiments of thepresent disclosure. These surgical devices are particularly well suitedfor placement via an anterior or anterolateral lumbar interbody fusionprocedure. These surgical devices comprise a medial module 1501, twoposterior modules 1503, 1505 and preferably a single adjustable armature907, which is comprised of nitinol or an equivalent material.

In use, one or more instruments or tools may be employed to pull andshape the Nitinol armature 1507 through an aperture 1517 in the medialmodule 1501 in order to compress the surgical device. After the surgicaldevice is in place, the insertion tool advances armature 1507 forward todeploy modules 1503, 1505 in a more posterior location relative to thedisc space. This surgical device preferably has a central opening orvoid 1516 for receiving graft material. The void 1516 may have anyshape. In one embodiment, the void 1516 has a shape that generallyconforms to the exterior shape of the medial module 1501. Modules 1503,1505 are preferably comprised of PEEK or an equivalent material.

FIGS. 71A-B and 72A-B are plan and perspective views of surgical devices1600, 1600A according to yet another alternate embodiment of the presentdisclosure. In these embodiments, which are similar to the embodimentsdescribed above in connection with FIGS. 68A-D, a threaded end 1619 isincorporated on the armature 1609. Accordingly, the devices 1600, 1600Aonly include primary module 1601, 1601A and secondary module 1605. Thethreaded end 1619 may be engaged by a tool of an insertion device, suchas IDD 10, to position or orient the surgical device 1600, 1600A withinthe space between adjacent vertebrae. The threaded end 1619 may also bemanipulated by the tool of the insertion device to change the positionor orientation of the armature 1609 with respect to the primary module1601, 1601A.

In one embodiment, the threaded end 1619 is slightly wider than theremainder of armature 1609, and may be secured to the threaded opening(not shown) of module 1601. This permits the armature 1609 to becomesecured in a final or deployed configuration once the threads engage thethreaded opening of module 1601. The surgical device also includes anaperture 1616 adapted to receive bone growth material and a profilednose 1618. The profiled nose is formed by reducing the width 1614 andthickness 1615 of the modules 1601, 1605 at the distal end compared tothe proximal end. An alternative embodiment of the surgical device 1600Ais shown in FIGS. 72A-B in which the armature 1609 has a generallylinear shape. FIGS. 72A-B further illustrate the threads 1619 secured inan opening of the module 1601. Module 1605 may also include an aperture1634 to deliver bone growth material through the device 1600A to thespace between adjacent vertebrae.

Referring now to FIGS. 73A-C, a surgical device 1700 of yet anotherembodiment of the present invention is illustrated. Surgical device 1700is similar to surgical devices 1300, 1400 described above in connectionwith FIGS. 67-68. The surgical device 1700 includes an adjustablearmature 1709 slidingly interconnected to a primary module 1701. Twomodules 1704, 1705 are positioned at opposite ends of the adjustablearmature 1709. Any of the external surfaces 1725 of the modules 1701,1704, 1705 may have patient-specific contours. In one embodiment, eachexternal surface 1725 of the modules includes a patient specificcontour. In another embodiment, only one of the modules includes patientspecific contours. In another embodiment, only the upper and lowersurfaces 1725 of the modules positioned proximate to an upper and lowervertebral body have patient specific contoured surfaces. FIG. 73Cillustrates an example of the surgical device 1700 in a deployedposition proximate to a vertebral body V.

The surgical device described herein may be used in a minimally invasivesetting, and may comprise one or more adjustable modules which may beassembled after delivery through a cannula or other minimally invasivepassageway to the surgical site. Alternatively, one or more portions ofan apparatus may be nested within another portion of the surgicaldevice, or alternatively nested within an instrument or other devicethat is used to deliver the apparatus through a cannula, tube or otherminimally-invasive portal.

FIGS. 74A-F and 75A-D are various perspective and plan views of surgicaldevices 1800, 1800A according to still more alternate embodiments of thepresent disclosure. According to these embodiments, the surgical devices1800, 1800A comprise a plurality of armatures 1803 that aresubstantially hollow between a top and a bottom surface that are adaptedto contact portions of upper and lower vertebral bodies. The number ofarmatures may vary, as illustrated in FIGS. 74A-F illustrated device1800 with five armatures 1803 and FIGS. 75A-D illustrating a surgicaldevice 1800A with four armatures 1803.

The medial portions 1801 of surgical devices 1800, 1800A include upper1801A and lower 1801B portions that are also preferably hollow with avoid 1804. The void may have any shape. The shape of the medial portions1801 and the void 1804 may be asymmetric. Further, the upper 1801Aportion and upper void 1804 may have a different size and shape than thelower 1801B portion and lower void 1804B. In one embodiment, the voidhas a shape similar to the shape of the medial portion 1801. In oneembodiment, devices 1800, 1800A are adapted to flex or compress inresponse in response to movement of the adjacent vertebrae. In anotherembodiment, devices 1800, 1800A are substantially rigid and resist orprevent compression. In this embodiment, webbing or transverse supportelements may be positioned between the upper and lower portions of themedial portion 1801 and the armatures 1803.

The lengths of armatures 1803 may be such that the medial portion 1801of each surgical device is placed substantially in the central portionof the disc space and the armatures extend only to the outer edge of theadjacent vertebrae, as best shown in FIGS. 74E-F and 75C-D. Eacharmature 1803 may have a unique length. The length of the armatures maybe determined based on the dimensions of a particular intervertebralspace of the patient.

The armatures 1803 may include projections 1802 that provide additionalstability and improved fit of the surgical device 1800 by slightlywrapping around the outer edge of adjacent vertebrae V, as illustratedin FIGS. 74E-F. The projections 1802 may also be adapted to preventcompression of the devices 1800, 1800A between the opposing vertebralbodies. In one embodiment, the projections 1802 have a shape similar toa spike or a hook to grip the vertebrae. Further, each of theprojections 1802 may have a unique size and a patient specific shapeselected to conform to predetermined portions of the patient's anatomy.

The surgical devices 1800, 1800A may be comprised of any of thematerials described above. In one embodiment, the armatures 1803 aremade of a flexible material. Thus, the armatures 1803 may be bent orreshaped during insertion of the surgical devices 1800, 1800A in theintervertebral space. In another embodiment, the armatures 1803 are madeof Nitinol or another material with shape memory. In one embodiment, thearmatures 1803 may be flexible axially. In this manner, the distance ofthe projections 1802 from the medial portion 1801 may be at leasttemporarily decreased. This may aid insertion of the device 1801, 1800Ainto the intervertebral space.

The size and shape of the surgical devices and armatures described aboveand illustrated in FIGS. 46-75 may be designed prior to surgery usingthe patient's unique morphology, which may be derived from captured froma MM or CT scan or from radiographic images of the patient'scorresponding boney anatomy (or alternatively from other data sources).The data, once captured, may be converted using known software tools toa CAD program, where the data set is representative of athree-dimensional model and may be used to provide additional datapoints for forming the contours, sizes, shapes and orientations of thesurgical devices 700-1900 to be used in the surgical procedure.

The surgical devices 700-1900 may then be fabricated by any method.Fabrication methods may comprise the use of a rapid prototyping machine,such as a stereolithography (STL) machine, selective laser sintering(SLS) machine, or a fused deposition modeling (FDM) machine, directmetal laser sintering (DMLS), electron beam melting (EBM) machine, orother additive manufacturing machine.

Embodiments of the present disclosure present several advantages overthe prior art including, for example, the speed and efficacy of theprocedure, the minimally invasive aspects of the procedure, thedisposability of the prototype devices, the ability to introduceimplants to the surgical site with minimal risk and damage to thesurrounding tissue, lower risk of infection, more optimally placedand/or oriented devices, a more stable and controlled method of placingand inserting of a surgical device, further reducing the likelihood ofthe apparatus becoming misaligned or dislodged, and fewer and/or lessexpensive tools and instruments in a surgical site, among otheradvantages. For example, the embodiments reduce the number and need formultiple trays, instruments and different size devices used in aparticular surgery, thereby reducing the cost of the equipment necessaryto complete the surgery.

According to another alternative embodiment, the system and method maycomprise providing the data set(s) to a CNC machine, which in turn maybe utilized to manufacture a custom milled apparatus from one of themore mechanically sound materials listed above. In yet anotheralternative embodiment, volume manufacturing of apparatus in accordancewith the embodiments described herein may also be achieved, for example,where a particular orientation or insertion trajectory is common among alarge grouping of patients.

To add further stability to the seating and placement of the surgicaldevices described herein to the patient anatomy, the modules may furthercomprise one or more spikes or teeth or other surface features, whichserve to contact and at least partially penetrate or “grip” the patientanatomy to secure the implant in place. In one embodiment, the surfacefeatures may be made of the same material and may be permanentlyattached to the modules. In another embodiment, the surface features maybe comprised of an overlay, and/or may be made of a different material,such as the ones described herein, and may further be selectivelyinserted onto one or more of the modules as desired.

According to further embodiments of the present disclosure, the patientcontacting surfaces, formed on the modules, including one or moreprotrusions extending from the primary modules 701-1901 of the surgicaldevices described in greater detail above (and according to severalembodiments disclosed herein) may comprise a sharp or semi-sharpcontacting edge for penetrating and affixing to the patient's anatomicalfeature. This is particularly important for spinal surgical procedureswhere the precise location of the patient contacting surface must bewithin a small degree of error, and must remain permanent throughout theprocedure.

In one embodiment, the surgical devices described above may be matchedto an anatomic feature of a patient that has degenerated and needs to berestored. In another embodiment, the surgical device may be necessary tocorrect structural or physiological deformities present in the patientanatomy, and thereby serve to correct position or alignment of thepatient anatomy. Other implants may be patient specific but do not servea restorative or other structural function (i.e., a hearing aid implantcasing).

The surgical devices described herein may be manufactured via additivemanufacturing. In the context of spinal implants, the surgical devicesmay be used in all approaches (anterior, direct lateral, transforaminal,posterior, posterior lateral, direct lateral posterior, etc). Specificfeatures of the surgical device can address certain surgical objectives,for example restoring lordosis, restoring disc height, restoringsagittal or coronal balance, etc.

Other applications contemplated by the present disclosure includeinterbody fusion implants, disc space height restoration implants,implants having footprint matching, surface area maximization, shape andcontour matching to endplates or other vertebral defects, and mayfurther specify the contact surface such as the relative degree ofroughness or other surface features. For example, an implant may befabricated based on the patient anatomy which further comprises adirection-specific shape, such that the implant may fit through anaccess portal and into the disc space without difficulty. Alternatively,the implant may be fabricated in a manner to account for anatomicconstraints both at the point of implant and through the path theimplant must travel, and may further compensate for anatomical defects.In the context of a spinal implant, the surgical device may furtherspecify a desired angle of lordosis or coronal defect correction,specify a patient specific height of the implant or (desired heightfollowing disc height restoration), specify a degree of expansionpermitted (for expandable implants), and may be unidirectional ormulti-directional depending on the surgery and the surgeon preference.

According to various embodiments described herein, the surgical devicesand associated fixation devices offer a significant improvement inimplant design. In the disclosed design, an interbody fusion device maybe placed from a bilateral posterior lumbar interbody fusion (PLIF) or aunilateral tranforaminal lumbar interbody fusion (TLIF) approach, andmay further become mechanically interlocked with a vertebral anchoringor fixation device. The fixation device may be, by way of example butnot limitation, a modified vertebral pedicle screw. One or more surgicalguides may be fabricated using patient data to provide a predictable andreproducible trajectory, and to ensure that the fixation devicesinserted through the guide interlock with the interbody fusion device.

The apparatus disclosed herein may be made of a variety of differentmaterials. These materials may include, by way of example but notlimitation, stainless steel, titanium alloy, aluminum alloy, chromiumalloy, and other metals or metal alloys. These materials may alsoinclude, for example, PEEK, carbon fiber, ABS plastic, polyurethane,resins, particularly fiber-encased resinous materials rubber, latex,synthetic rubber, synthetic materials, polymers, and natural materials.

According to one aspect of the present disclosure, the surgical devices700-1800 described herein may be used with at least one instrument ortool for delivering and manipulating the implant.

The present disclosure may also be advantageous in light of recentimprovements in decentralized manufacturing. For example, surgicaldevices may soon be capable of fabrication in a number of different andconvenient settings, including but not limited to an off-sitemanufacturing location, an on-site manufacturing location, usingequipment present in a surgeon's clinic or offices or in a public orprivate hospital. For example, modules may be fabricated based on aparticular patient need and immediately fabricated once the need isidentified, and then provided directly to the surgeon.

While various embodiment of the present disclosure have been describedin detail, it is apparent that modifications and alterations of thoseembodiments will occur to those skilled in the art. However, it is to beexpressly understood that such modifications and alterations are withinthe scope and spirit of the present disclosure, as set forth in thefollowing claims. For further illustration, the information andmaterials supplied with the provisional and non-provisional patentapplications from which this application claims priority are expresslymade a part of this disclosure and incorporated by reference herein intheir entirety.

It is expressly understood that where the term “patient” has been usedto describe the various embodiments of the disclosure, the term shouldnot be construed as limiting in any way. For instance, a patient couldbe either a human patient or an animal patient, and the apparatus andmethods described herein apply equally to veterinary science as theywould to surgical procedures performed on human anatomy. The apparatusand methods described herein therefore have application beyond surgicalprocedures used by spinal surgeons, and the concepts may be applied toother types of “patients” and procedures without departing from thespirit of the present disclosure.

The foregoing discussion of the disclosure has been presented forpurposes of illustration and description. The foregoing is not intendedto limit the disclosure to the form or forms disclosed herein. In theforegoing Detailed Description for example, various features of thedisclosure are grouped together in one or more embodiments for thepurpose of streamlining the disclosure. This method of disclosure is notto be interpreted as reflecting an intention that the claimed disclosurerequires more features than are expressly recited in each claim. Rather,as the following claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the followingclaims are hereby incorporated into this Detailed Description, with eachclaim standing on its own as a separate preferred embodiment of thedisclosure.

Moreover, though the present disclosure has included description of oneor more embodiments and certain variations and modifications, othervariations and modifications are within the scope of the disclosure,e.g., as may be within the skill and knowledge of those in the art,after understanding the present disclosure. It is intended to obtainrights which include alternative embodiments to the extent permitted,including alternate, interchangeable and/or equivalent structures,functions, ranges or steps to those claimed, whether or not suchalternate, interchangeable and/or equivalent structures, functions,ranges or steps are disclosed herein, and without intending to publiclydedicate any patentable subject matter. cm What is claimed is:

1. A spinal implant adapted for insertion in a space between adjacentvertebrae, comprising: a primary module; a first adjustable armature anda second adjustable armature each interconnected to the primary module,the first and second adjustable armatures each associated with a borethrough the primary module and each including a proximal end with aproximal module and a distal end with a distal module; wherein the firstand second adjustable armatures are configured to move in relation tothe primary module to change positions of the proximal and distalmodules; and wherein the proximal modules are positioned on a first sideof the primary module and the distal modules are positioned on a secondside of the primary module, opposite to the first side of the primarymodule.
 2. The spinal implant of claim 1, wherein the first and secondarmatures are formed of a flexible material.
 3. The spinal implant ofclaim 1, wherein the first and second armatures are formed of a shapememory material.
 4. The spinal implant of claim 1, wherein at least oneof the first and second armatures is substantially linear.
 5. The spinalimplant of claim 1, wherein at least one of the first and secondarmatures has a generally arcuate shape.
 6. The spinal implant of claim1, wherein at least a portion of each of the distal modules is thinnerthan the primary module.
 7. The spinal implant of claim 1, furthercomprising a void in the primary module, wherein the void is adapted toreceive implant material.
 8. The spinal implant of claim 1, wherein eachof the proximal and distal modules are selectively connectable to therespective first and second adjustable armatures.
 9. The spinal implantof claim 1, wherein the bores through the primary module arecylindrical.
 10. The spinal implant of claim 1, further comprising alocking mechanism to maintain the first and second adjustable armaturesin a desired position.
 11. The spinal implant of claim 10, wherein theimplant comprises an aperture located in the primary module and adjacentat least one of the first and second adjustable armatures, and whereinthe aperture is adapted to receive a threaded fixture that can berotated to apply a force to the at least one of the first and secondadjustable armatures to prevent movement of the at least one adjustablearmature relative to the primary module.
 12. The spinal implant of claim1, wherein one or more of the proximal and distal modules comprise atapered leading edge.
 13. The spinal implant of claim 1, wherein theimplant has an initial or insertion configuration with a first widthsized to be received between the adjacent vertebrae.
 14. The spinalimplant of claim 13, wherein the implant has a second or deployedconfiguration with a second width that is greater than the first width.